Comparison of fixation technologies

2 Comparison of fixation technologies

Table of contents Unique properties of Chrisofix products............. 4. Finger and mallet finger splints.......... 5. Metacarpal and thumb ortheses......... 6. Chrisofix Forte can replace POP and similar fixations....... 7. Scaphoid orthesis............. 7. Wrist & thumb orthesis for emergency... 7. Metacarpal IV-V ortheses........... 8. De Quervain orthesis.... 8. Carpal tunnel syndrome: clinical studies and products...... 9-11. Thumb saddle joint osteoarthritis: clinical studies and products... 12-15. Dorsal and volar ortheses........... 16. Palmar ortheses............ 17-19. Elbow ortheses............. 20. Foot corrector for babies......... 20. Infusion splints........ 21. Resting ortheses for lower limb Ankle & Achilles....... 22. Knee....... 23. Lower limb...... 23. Reusable resting shells for hospital use..... 24-25. Chest orthesis for fractured ribs......... 26-27. Splints for first aid and sport injuries........... 28-29. Accessories Exchangeable terry-cloth liners.......30-31. 3

Unique properties of Chrisofix products Chrisofix technology and products have been developed by Dr. K. Bolla, founder of Chrisofix Ltd. (Schaffhausen, Switzerland). The manufacturing of the Chrisofix products was started at Orkrisz Ltd. (Budapest) in 1997. Since then, Chrisofix Ltd. has been continuously extending its product range by developing new, patent-protected technologies and products. The main component of the Chrisofix products is a thin, corrugated aluminum core embedded in cotton-laminated foam on the inside and velour-coated polyethylene foam on the outside of the orthotic device. Since 2008 the Chrisofix technology has been extended with the systemic use of the patented Forte straps. The Forte straps made it first possible to develop quickly applicable, POP-like circular stable ortheses without water or heat, i.e. replace plaster or thermoplastic fixation with orthesis. This step extended the advantages resulted by the combination of semi-circular, well adjustable fixation (e.g., plaster of Paris, or thermoplastic materials) and those of the quickly applicable but only segmental stable ortheses. Due to our technology all Chrisofix ortheses ensure semicircular or circular stable quick fixation. they are adjustable and readjustable without water or heat, in seconds. all products are form-keeping and adjustable to the limb at the same time. most of traditional splints/ortheses and custom-made thermoplastic products can be replaced with Chrisofix ortheses. earlier unrealizable therapeutic ideas have become part of daily therapy - chest orthesis for rib fracture - quick interchangeability of an immobilizing night splint to a less restricting one for the daytime some Chrisofix Forte products can be used instead of plaster of Paris on upper limb before or after surgery allowing: - earlier start of controlled physiotherapy - more convenient daily hygiene. 4

Finger splints (ortheses) For immobilisation of the finger First aid Fixation of fingers II-V in case of injury, inflammation (e.g. panaritium), degenerative diseases and/or following surgery on the distal and/or middle phalanges and/or on the interphalangeal joints NEW length of splint FIRST AID & SPORT STANDARD BASIC XXXS (children small) 4.3 cm - 101 123 104 101 121 104 XXS (children large ) 5.5 cm 022 127 102 102 123 104 102 121 104 S (small) 6.5 cm 024 127 102 104 123 104 104 121 104 L (large) 7.2 cm 028 127 102 108 123 104 108 121 104 XL (extra large) 9.7 cm - 109 123 104 109 121 104 Set of 2 pieces (S+L) 020 127 102 - - The splint is covered with polyethylene outside, and padded with cotton inside. The splint is covered with a film layer outside, and padded with cotton inside. The splint is covered with blue velour outside, and padded with cotton inside. Mallet finger splints (ortheses) For immobilisation of the fingertip First aid Immobilisation for felons or injuries of the fingertip or nail bed Conservative treatment for extensor tendon ruptures or fractures of the distal phalanx Immobilisation following surgery on the DIP joint or on the distal phalanx Rehabilitation after stroke NEW length of splint STANDARD - SIMPLE STANDARD - OVERLAPPING BASIC S (small) 4 cm 114 123 104 114 123 103 124 121 101 M (medium) 5 cm 116 123 104 116 123 103 126 121 101 L (large) 6 cm 118 123 104 118 123 103 128 121 101 The splint is covered with a film layer outside, and padded with cotton inside. The splint is covered with a film layer outside, and padded with cotton inside. The splint is covered with blue velour outside, and padded with cotton inside. 5

Metacarpal ortheses For immobilisation of the joints of the fingers II-IV, including the metacarpophalangeal ones First aid, initial treatment Isolated fixation of the basic joint of the fingers II-IV (short version) or combined fixation of all the joints of these fingers including the metacarpophalangeal one in case of injuries, inflammations (e.g. felons), degenerative diseases and following surgery FIRST AID & SPORT INJURIES (short) children <7.5 cm 272 129 104 adult 7.5< cm 276 129 104 FORTE (long) XXS (children large ) <7 cm 262 121 183 S (small) 7-8 cm 264 121 183 L (large) 8< cm 268 121 183 Thumb ortheses (MCP) For immobilisation of the metacarpophalangeal I. joint First aid Fixation of the metacarpophalangeal joint of the thumb in case of injuries (e.g. strain or sprain), inflammation (e.g. tenosynovitis), degenerative diseases and following surgery FIRST AID & SPORT INJURIES IP joint of the thumb - line of wrist FORTE children <7.5 cm 162 129 107 adults 7.5< cm 166 129 107 IP joint of the thumb - line of wrist XXS (children large) <7 cm 162 121 187 S (small) 7-8 cm 164 121 187 M (medium) 8-9 cm 166 121 187 L (large) 9< cm 168 121 187 Extended thumb orthesis For immobilisation of MCP I. joint, extended to the saddle joint NEW First aid Fixation of the metacarpophalangeal joint of the thumb in case of injuries (e.g. strain or sprain), inflammation (e.g. tenosynovitis), degenerative diseases and following surgery Functional immobilisation of saddle joint FORTE S (small) <8 cm 234 121 186 244 121 186 M (medium) 8-9 cm 236 121 186 246 121 186 L (large) 9< cm 238 121 186 248 121 186 6

Some POP-like fixations can be replaced with CHRISOFIX Forte ortheses Due to the aluminium containing straps, the Chrisofix Forte products ensure a POP-like stable circular fixation. All these products (some examples are below) can be applied and removed without water or heat in seconds. Consequently, many fixations with plaster of Paris, thermoplastic techniques and similar ones can be replaced with Chrisofix Forte products. Tendonitis, fracture-related temporary fixations, movement-stable osteosyntheses, immobilisation before and after hand surgery, all belong to the indication field of this product family. The use of the Chrisofix Forte products results in substantial advantages, e.g. time saving, sparing on the costs of raw materials, patient s convenience with respect to daily hygiene and earlier start of physiotherapy, etc. 7 Scaphoid orthesis For immobilisation of the carpal bones FORTE S (small) <8 cm 354 111 182 364 111 182 M (medium) 8-9 cm 356 111 182 366 111 182 L (large) 9< cm 358 111 182 368 111 182 Liner is available (page 30.) Wrist & thumb orthesis for emergency For immobilisation of the wrist and the thumb Immobilisation of the carpal region after injuries, especially in case of Scaphoid fracture before and after surgery Initial fixation after wrist injuries and/or following surgery or initial POP fixation in case of extended involvement of tendons. FORTE S (small) <8 cm 584 121 181 594 121 181 M (medium) 8-9 cm 586 121 181 596 121 181 L (large) 9< cm 588 121 181 598 121 181 7

Short metacarpal IV-V orthesis For immobilisation of the basic (MCP) joints of fingers IV-V Immobilisation of the basic (MCP) joints of fingers IV-V after injuries and following surgery on flexor tendons or osteosynthesis FORTE PIP joint of finger V - line of the wrist S (small) <10.5 cm 284 121 186 294 121 186 M (medium) 10.6-11.9 cm 286 121 186 296 121 186 L (large) 12< cm 288 121 186 298 121 186 Long metacarpal IV-V orthesis For immobilisation of the wrist and the basic (MCP) joints of fingers IV-V Immobilisation of the wrist and the basic (MCP) joints of the fingers IV-V including the metacarpal bones after injuries and following surgery on flexor tendons or osteosynthesis FORTE with liner PIP joint of finger V - line of the wrist S (small) <10.5 cm 564 121 176 574 121 176 M (medium) 10.6-11.9 cm 566 121 176 576 121 176 L (large) 12< cm 568 121 176 578 121 176 The orthesis is delivered with exchangeable liner. Additional liner is available (page 30.) Orthesis for De Quervain Syndrome For De Quervain s tenosynovitis NEW Extended immobilisation of the thumb to the forearm for blocking all possible movements within the synovial sheaths, trough which the tendons of the thumb abductors (extensor pollicis brevis and abductor pollicis longus) pass. FORTE with liner length of thumb S (small) <5.5 cm 514 121 171 524 121 171 M (medium) 5.5-6.5 cm 516 121 171 526 121 171 L (large) 6.5< cm 518 121 171 528 121 171 The orthesis is delivered with exchangeable liner. Additional liner is available (page 30.) 8

DAY and NIGHT A CHANCE TO AVOID SURGERY THE QUICK AND SIMPLY EXCHANGEABLE CIRCULAR STABLE FIXATION HAS OPENED UP NEW HORIZONS IN THE THERAPEUTIC FIXATION TECHNIQUES The commercially available splints/ortheses restrict the movement only in one or two directions. Consequently, the efficacy of the fixation with them can be also only limited in syndromes where immobilization would be desirable. In such indications, a circular stable fixation provides a far better efficacy. The quick interchangeability of such night splint to a less movement-restricting one for day time activities is another important benefit of this new permanent splinting treatment. SPLINTING IN CARPAL TUNNEL SYNDROME (CTS) Functional CTS orthesis for daytime activities CTS orthesis for night and rest Remarks to the pathomechanism The immediate cause of carpal tunnel syndrome (CTS) is an increase of the local pressure in the carpal tunnel. Illnesses, genetic and environmental factors (e.g., hormonal diseases, obesity, pregnancy, heavy manual work or work with vibrating tools, etc.) or even their combinations may contribute to the development of the increased pressure. In addition, the movement of the wrist has been shown to be a steady state increasing factor in the regulation of the tunnel pressure (George S. Phalen: 1966). In spite the fact, that improvement in CTS has also been reported after using of wrist splints that only restrict the movement in one or two directions, we claim that significantly more efficient treatment can be provided by the Chrisofix CTS ortheses, which ensure a circular stable fixation like POP. Considering the differences between the requirements of the resting and working splints, two different Chrisofix CTS Wrist Ortheses have been developed for long-lasting (at least for 4-6 weeks) continuous therapy. Interruptions are proposed to limit only for the time of the daily hygiene. The Chrisofix CTS Wrist Orthesis which ensures a virtual immobilization of the wrist in neutral position is proposed for the night or at rest. The Functional CTS orthesis is more comfortable and allows minimal movement in the wrist; it has been developed for painless performing the daily activities. Hygienic aspects are also supporting the regular changing of the two ortheses. Explorative clinical study: During a 4-6 week long exploratory study 23 neurologically confirmed CTS cases were monitored, in which 5 men and 13 women participated (5 of them with bilateral symptoms). Their age ranged between 9

23 and 80, the existence of their disease ranged from a few months to several years. The patients should have worn the Chrisofix CTS orthesis for 24 hours if possible, but most of them used it only at night. Therefore, we developed a more comfortable version: the earlier mentioned Functional CTS Orthesis dedicated to daytime use. The limitation of daytime activities and the severity of symptoms were assessed with the help of the Boston questionnaire at the beginning and end of the observation period. The results are presented in a graphic and a table on the next page. A significant improvement was observed in all examined parameters (Wilcoxon-test; p<0.01). The number of patients (n=18), for whom the nigh time rest was undisturbed increased from 1 to 9; for those who characterized their symptoms with less than 10% of the maximum score increased from 2 to 11 (Chix2 test: p<0.01). Due to the small number of patients, the statistical interpretation of these observations is extremely limited. Even thought, the observations clearly support our initial assumption that: a circular orthesis with POP-like stability is more effective in CTS, than the commercially available ones with only segmental stability. Results of the evaluated Boston questionnaires Median 25 20 15 10 5 0 (min-max) (0-40) (0-16) (1-21) (0-19) (0-21) (1-22) (0-25) (0-12) (0-4) (0-12) 1 2 3 4 5 before splinting after splinting 1 = impairment of daily activities 2 = symptoms severity scores total 3 = wake-up related scores (frequency & severity) 4 = pain-related scores (frequency & severity) 5 = paresthesia-related scores (frequency & severity) The algorithm of the recommended treatment scheme Symptoms day & night Splints day & night for 4-6 weeks Improvement Symptom free Worsening Symptoms only night Night splint for 4-6 weeks Symptom free Worsening Improvement Long-time night splint or trial without splinting SURGERY 10

Wrist orthesis for Carpal Tunnel Syndrome For immobilisation of the wrist (CTS) Immobilisation of wrist for rest and night in carpal tunnel syndrome Fixation or immobilisation of the wrist after injuries (e.g. distortion), surgery and fixation with plaster of Paris Conservative treatment in tendonitis, inflammation and degenerative diseases of the wrist Rehabilitation phase after fractures and hand surgery FORTE with liner S (small) <8 cm 334 111 175 344 111 175 M (medium) 8-9 cm 336 111 175 346 111 175 L (large) 9< cm 338 111 175 348 111 175 The orthesis is delivered with exchangeable liner. Additional liner is available (page 30.) Functional wrist orthesis for Carpal Tunnel Syndrome Immobilisation of the wrist (CTS) for daily activities Immobilisation of wrist for daily activities in carpal tunnel syndrome Fixation or immobilisation of the wrist after injuries (e.g. distortion), surgery and fixation with plaster of Paris Conservative treatment in tendonitis, inflammation and degenerative diseases of the wrist Rehabilitation phase after hand surgery FORTE S (small) <8 cm 434 121 182 444 121 182 M (medium) 8-9 cm 436 121 182 446 121 182 L (large) 9< cm 438 121 182 448 121 182 Primarily recommended for daytime activities Postoperative (CTS) wrist orthesis For accelerated recovery after carpal surgery NEW After Carpal Tunnel surgery for wound protection FORTE S (small) <8 cm 314 111 181 324 111 181 M (medium) 8-9 cm 316 111 181 326 111 181 L (large) 9< cm 318 111 181 328 111 181 11

Forte SADDLE JOINT ORTHESES FOR A BETTER LIFE QUALITY Habitual overnight immobilization for painless days without medication Effective immobilization of thumb is the precondition of optimal efficacy

THUMB SADDLE JOINT ORTHESES FORTE The osteoarthritis of the thumb is one of the most frequent degenerative joint disorders (3-4 times more frequent by females than males). The prevalence of patients with active symptoms is assumed to be about 10% of the population over 60 years. The leading symptom is pain at base of thumb which occurs by grasping or peak-catching (taking the objects between thumb and index finger, opening a bottle, turning key, etc.). Sudden sharp pain may result in dropping of the grabbed object. In most cases, the symptoms develop gradually. Constant discomfort and symptom-free periods may vary over years. The pain might persist at rest, too and the alteration may result eventually in deformities. The origin of primary osteoarthritis of saddle joint is multi-factorial, i.e., not clearly known. Yet, micro-traumas (overwork/ exhaustion) are generally assumed to participate in the background of thumb saddle joint osteoarthritis. Due to altered statics of the joint and its affected surface/s, the movement of the thumb triggers at least two self-generating process: 1. static alterations cartilages destruction aggravation of static alterations 2. cartilages destruction (in absence of steady state II.) inflammation aggravation of cartilages destruction The central role of movement in assumed mechanism of osteoarthritis (see above) clearly shows the importance of a quickly applicable immobilizing orthosis. The circular stable Chrisofix Forte orthoses fulfil these requirements. Sporadic clinical observations and conclusions of small explorative studies have indicated more detailed investigation/s on habitual overnight immobilization with Chrisofix Forte Wrist & Thumb Orthosis in thumb saddle joint osteoarthritis. Habitual overnight immobilization as single therapy significantly improves the clinical symptoms, functionality of hand and life quality of patients with CMC osteoarthritis (J. Hand Surg. (Eur) 42 Suppl. 1. P:191). 27 patients with thumb osteoarthritis (X-ray: II-III stages) were involved into the study. Spontaneous and provoked pain (VAS) in various situations and the patients' ability to perform functional tests at the start of the study, as well as 3 and 6 weeks later were assessed. In addition, 17 patients reported on life quality-related standardized question (quick DAS) at the start and end of the study, too. The overnight immobilization with Chrisofix Forte orthosis was the only allowed therapy. Methods Pain assessments reported by the patients: night pain, pain at rest, pain during the daily activities Pain assessments in presence of the physician: at pressure and at performing four different functional tests Performing functional tests: thumb adduction, by holding firm a pétanque ball, holding a bottle by the cap, and by twisting off the cap of a bottle 13

THUMB SADDLE JOINT ORTHESES FORTE Characteristic examples from the results: Changes (mean of 27 pts) in situation-dependent pain severity (VAS%) during the study Occurance of disturbing pain after awakening (n=27; p<0,0000) Start 1st control morning End of study afternoon none study start 1. control 2. control Patients able/not able to open the bottle (n=27); p<0,00 Number of patients (17) who assesed the severity of life quality disturbing factors based on 10 targeted questions Start of study Life quality End of study Not disturbing Disturbing Strongly disturbing Extremely disturbing <2 >2 >3 >4 study start 1. control 2. control Ongoing follow up investigations 1,5 year after finishing the study (17 pts by the time) Changes (mean of 17 pts) in situation-dependent pain severity (VAS%) during the study Number of patients (12) who assesed the severity of life quality-disturbing factors based on 10 targeted questions Start End of study Follow up Start End of study Follow up Disturbing >2 Extremely disturbing >4 Not disturbing <2 Strongly disturbing >3 All parameters improved significantly (p<0,05) during the observation period. The improvements correlated (p<0,05) with the duration of the treatment period. The effect of habitual overnight immobilization persisted in the follow up period, too. The results strongly suggest to use immobilizing orthoses instead of NSAIDs as primary therapy for thumb osteoarthritis PROPOSED STRATEGY FOR THE FIXATION THERAPY Habitual overnight use of the corresponding Chrisofix Forte Saddle Joint Orthesis Short-term temporary use of the functional orthosis versions if necessary during the day Leaving off NSAIDs 14

Saddle joint orthesis For immobilisation of the saddle joint - during the night (resting splint) Immobilisation of the metacarpophalangeal (MCP) and saddle (CMC) joints of the thumb. Especially for saddle (CMC) joint arthrosis, distortions, post-fracture stages of the thumb and following surgery related to this region, even as night splint FORTE S (small) <8 cm 144 121 183 154 121 183 M (medium) 8-9 cm 146 121 183 156 121 183 L (large) 9< cm 148 121 183 158 121 183 Wrist & saddle joint orthesis For immobilisation of the wrist (inc. saddle joint) and basic (MCP) joint of the thumb - during the night (resting splint) Immobilisation of the wrist and metacarpophalangeal (MCP) joint of the thumb. Especially for saddle (CMC) joint arthritis, tenosynovitis, distortions, post-fracture stages of the thumb and following surgery related to these joints and region FORTE with liner S (small) <8 cm 374 121 172 384 121 172 M (medium) 8-9 cm 376 121 172 386 121 172 L (large) 9< cm 378 121 172 388 121 172 The orthesis is delivered with exchangeable liner. Additional liner is available (page 30.) Extended thumb orthesis (Functional saddle joint orthesis) For immobilisation of the MCP I. joint, extended to the saddle joint NEW First aid Fixation of the metacarpophalangeal joint of the thumb in case of injuries (e.g. strain or sprain), inflammation (e.g. tenosynovitis), degenerative diseases and following surgery Functional immobilisation of saddle joint FORTE S (small) <8 cm 234 121 186 244 121 186 M (medium) 8-9 cm 236 121 186 246 121 186 L (large) 9< cm 238 121 186 248 121 186 Functional wrist & saddle joint orthesis For immobilisation of the basic (MCP) and saddle (CMC) joints of the thumb Immobilisation in saddle joint osteoarthritis For distortions, inflammatory states and states following surgery related to this region FORTE with liner S (small) <8 cm 644 121 172 654 121 172 M (medium) 8-9 cm 646 121 172 656 121 172 L (large) 9< cm 648 121 172 658 121 172 The orthesis is delivered with exchangeable liner. Additional liner is available (page 30.) 15

Volar wrist ortheses SHELL (Polyethylene/Cotton) For fixation of the wrist First aid and first care: transitory fixation before or just after surgery (specially after surgery for carpal tunnel syndrome) Fixation or immobilisation (Forte version) of the wrist after injuries (e.g. distortion), surgery and fixation with plaster of Paris Conservative treatment in tendonitis, inflammation and degenerative diseases of the wrist, even as resting splints Rehabilitation phase after hand surgery Dorsal wrist ortheses SHELL (Polyethylene/Cotton) 701 117 146 XXXS (children small) < 6 cm 721 117 146 702 117 146 XXS (children large ) 6-6.5 cm 722 117 146 703 117 146 XS (extra small) 6.6-7.5 cm 723 117 146 704 117 146 S (small) 7.6-8 cm 724 117 146 706 117 146 M (medium) 8.1-9 cm 726 117 146 708 117 146 L (large) 9< cm 728 117 146 SHELL (Blue velour/cotton) SHELL (Blue velour/cotton) In green colour: 70_ 119 146 BASIC 701 111 146 XXXS (children small) < 6 cm 721 111 146 702 111 146 XXS (children large ) 6-6.5 cm 722 111 146 703 111 146 XS (extra small) 6.6-7.5 cm 723 111 146 704 111 146 S (small) 7.6-8 cm 724 111 146 706 111 146 M (medium) 8.1-9 cm 726 111 146 708 111 146 L (large) 9< cm 728 111 146 In green colour: 72_ 119 146 BASIC 701 111 106 XXXS (children small) < 6 cm 721 111 106 702 111 106 XXS (children large ) 6-6.5 cm 722 111 106 703 111 106 XS (extra small) 6.6-7.5 cm 723 111 106 704 111 106 S (small) 7.6-8 cm 724 111 106 706 111 106 M (medium) 8.1-9 cm 726 111 106 708 111 106 L (large) 9< cm 728 111 106 Liner is available (page 30.) 16

Palmar forearm ortheses For immobilisation of the wrist, hand and fingers First aid and first care (transitory fixation before or just after surgery) Combined fixation or immobilisation (Forte version) of the wrist, hand and fingers after injuries (e.g. distortion), surgery and fixation with plaster of Paris Conservative treatment in tendonitis, inflammation and degenerative diseases of the wrist, hand and fingers even as resting splint Rehabilitation phase after hand surgery Adjuvant therapy in Sudeck-dystrophy SHELL (Polyethylene/Cotton) length of hand XXXS (children small) <14.5 cm 711 117 146 XXS (children large ) 14.5-15.5 cm 712 117 146 XS (extra small) 15.5-16.5 cm 713 117 146 S (small) 16.5-17.5 cm 714 117 146 M (medium) 17.5-19 cm 716 117 146 L (large) 19< cm 718 117 146 SHELL (Blue velour/cotton) length of hand XXXS (children small) <14.5 cm 711 111 146 XXS (children large ) 14.5-15.5 cm 712 111 146 XS (extra small) 15.5-16.5 cm 713 111 146 S (small) 16.5-17.5 cm 714 111 146 M (medium) 17.5-19 cm 716 111 146 L (large) 19< cm 718 111 146 In green colour: 71_ 119 146 BASIC length of hand XXXS (children small) <14.5 cm 711 111 106 XXS (children large ) 14.5-15.5 cm 712 111 106 XS (extra small) 15.5-16.5 cm 713 111 106 S (small) 16.5-17.5 cm 714 111 106 M (medium) 17.5-19 cm 716 111 106 L (large) 19< cm 718 111 106 Liner is available (page 30.) FORTE length of hand XXXS (children small) <14.5 cm 711 111 186 XXS (children large ) 14.5-15.5 cm 712 111 186 XS (extra small) 15.5-16.5 cm 713 111 186 S (small) 16.5-17.5 cm 714 111 186 M (medium) 17.5-19 cm 716 111 186 L (large) 19< cm 718 111 186 Liner is available (page 30.) 17

Palmar forearm ortheses with thumb support For immobilisation of the wrist, hand, fingers and thumb First aid and first care (transitory fixation before or just after surgery) Combined fixation or immobilisation (Forte version) of the wrist, hand, fingers and thumb after injuries (e.g. distortion), surgery and fixation with plaster of Paris Conservative treatment in tendonitis, inflammation and degenerative diseases of the wrist, hand, thumb and fingers even as resting splints Rehabilitation phase after hand surgery Adjuvant therapy in Sudeck-dystrophy SHELL (Polyethylene/Cotton) length of hand XS (extra small) <16.5 cm 733 118 149 743 118 149 S (small) 16.5-17.5 cm 734 118 149 744 118 149 M (medium) 17.5-19 cm 736 118 149 746 118 149 L (large) 19< cm 738 118 149 748 118 149 SHELL (Blue velour/cotton) length of hand XS (extra small) <16.5 cm 733 111 149 743 111 149 S (small) 16.5-17.5 cm 734 111 149 744 111 149 M (medium) 17.5-19 cm 736 111 149 746 111 149 L (large) 19< cm 738 111 149 748 111 149 In green colour: : 73_ 119 149 : 74_ 119 149 BASIC length of hand XS (extra small) <16.5 cm 733 111 109 743 111 109 S (small) 16.5-17.5 cm 734 111 109 744 111 109 M (medium) 17.5-19 cm 736 111 109 746 111 109 L (large) 19< cm 738 111 109 748 111 109 Liner is available (page 30.) FORTE length of hand XS (extra small) <16.5 cm 733 111 189 743 111 189 S (small) 16.5-17.5 cm 734 111 189 744 111 189 M (medium) 17.5-19 cm 736 111 189 746 111 189 L (large) 19< cm 738 111 189 748 111 189 Liner is available (page 30.) 18

Palmar ortheses for spastic paresis For immobilisation of the wrist, hand, fingers and thumb Immobilisation of the wrist, hand and fingers before and after phyrsiotherapy of patients with spastic paresis PALMAR ORTHESIS FORTE PLUS length of hand XXXS (children small) <14.5 cm 711 111 166 XXS (children large ) 14.5-15.5 cm 712 111 166 XS (extra small) 15.5-16.5 cm 713 111 166 S (small) 16.5-17.5 cm 714 111 166 M (medium) 17.5-19 cm 716 111 166 L (large) 19< cm 718 111 166 The extra stability of this orthesis is assured trough the external stiffener bar. Liner is available (page 30.) PALMAR ORTHESIS WITH THUMB SUPPORT FORTE PLUS length of hand XS (extra small) <16.5 cm 733 111 169 743 111 169 S (small) 16.5-17.5 cm 734 111 169 744 111 169 M (medium) 17.5-19 cm 736 111 169 746 111 169 L (large) 19< cm 738 111 169 748 111 169 The extra stability of this orthesis is assured trough the external stiffener bar. Liner is available (page 30.) 19

Elbow orthesis - With adjustable angle of 90-110 For fixation of the elbow : Fixation of the elbow following injuries and surgery SHELL elbow - finger base BASIC 801 111 147 XXXS (children small) <20 cm 801 111 107 802 111 147 XXS (children large ) 20-22 cm 802 111 107 803 111 147 XS (extra small) 22-26 cm 803 111 107 804 111 147 S (small) 26-30 cm 804 111 107 806 111 147 M (medium) 30-34 cm 806 111 107 808 111 147 L (large) 34< cm 808 111 107 80_ 119 147 In green colour 80_ 119 107 20 Elbow and wrist orthesis - With adjustable angle of 90-110 For fixation of the elbow and wrist : Fixation of the elbow and wrist (pronation and supination inhibited) following injuries and surgery SHELL elbow - finger base FORTE 771 111 147 XXXS (children small) <20 cm 771 111 187 772 111 147 XXS (children large ) 20-22 cm 772 111 187 773 111 147 XS (extra small) 22-26 cm 773 111 187 774 111 147 S (small) 26-30 cm 774 111 187 776 111 147 M (medium) 30-34 cm 776 111 187 778 111 147 L (large) 34< cm 778 111 187 77_ 119 147 - - In green colour Basic version - blue Basic version - green Liner is available (page 30.) - 77_ 111 107 77_ 119 107 Foot corrector for babies For correction of congenital deformities of the foot For correction of congenital deformities of the foot (ped adductus, pes calcaneus, pes supinatus) For ensuring the correction of foot abnormalities after surgery or after the application of a circular plaster cast FORTE with terry-cloth liner length of the foot XXXS (children small) 7.5 cm 411 121 173 421 121 173 XXS (children large) 9 cm 412 121 173 422 121 173 XS (extra small) 10.5 cm 413 121 173 423 121 173 The orthesis is delivered with removable spongy liner. Liner is available (page 31.) REMARKS The very light device does not burden the baby in any way and has an extremely low risk for inducing decubitus. It is easy for professionals to make corrective readjustments and also the parents can easily remove the device for hygienic purposes and reapply it. 20

Infusion splints INFUSION SHELL/SPLINTS FOR BABIES length of splint STANDARD SHELL REUSABLE XXXS (children small) 11 cm 401 114 101 401 114 141 401 012 141 XXS (children large) 17.5 cm 402 114 101 402 114 141 402 012 141 XS (extra small) 22 cm 403 114 101 403 114 141 403 012 141 INFUSION SPLINT FOR ADULTS Fixation: with the textile straps delivered with the device. (Polyethylene/ Cotton) Fixation: with optional bandages. (Polyethylene/ Cotton) Fixation: with optional bandages. (Polyethylene/ Polyethylene) length of splint Adults 24.5 cm 664 111 181 The splint is covered with polyethylene outside and padded with cotton inside. DIALYSIS SHELL ARTERIAL INFUSION SHELL length & width of splint XXS (children large) 45 cm; 18 cm 612 117 141 S (small) 53 cm; 20 cm 614 117 141 M (medium) 53 cm; 24 cm 616 117 141 The splint is covered with polyethylene outside and padded with cotton inside. length of splint S (small) 33 cm 624 117 141 The splint is covered with polyethylene outside and padded with cotton inside. CUBITAL / IV-LINE SHELL length of splint M (medium) 34.5 cm 636 117 141 The splint is covered with polyethylene outside and padded with cotton inside. SPLINT FOR RADIAL ARTERY CANNULATION NEW S (small) < 8 cm 674 111 181 M (medium) 8 < cm 676 111 181 21

Resting ortheses for ankle & Achilles For fixation of the foot and ankle Short-term fixation of the ankle region (incl. Achilles tendon) and foot following injuries and surgery length of the foot SHELL (Green velour/cotton) BASIC FORTE XXXS (children small) <18 cm 751 119 144 751 119 104 751 111 184 XXS (children large ) 18-20 cm 752 119 144 752 119 104 752 111 184 XS (extra small) 20-22 cm 753 119 144 753 119 104 753 111 184 S (small) 23-24.5 cm 754 119 144 754 119 104 754 111 184 M (medium) 25-27.5 cm 756 119 144 756 119 104 756 111 184 L (large) 27.5< cm 758 119 144 758 119 104 758 111 184 In blue colour: 75_ 111 144 75_ 111 104 - Liner is available: - page 31. page 31. Resting ortheses for ankle - Open at the Achilles tendon For fixation of the foot and ankle Short-term fixation of the ankle region and foot following injuries and surgery length of the foot SHELL (Green velour/cotton) BASIC FORTE XXXS (children small) <18 cm 821 119 143 821 119 103 821 111 183 XXS (children large ) 18-20 cm 822 119 143 822 119 103 822 111 183 XS (extra small) 20-22 cm 823 119 143 823 119 103 823 111 183 S (small) 23-24.5 cm 824 119 143 824 119 103 824 111 183 M (medium) 25-27.5 cm 826 119 143 826 119 103 826 111 183 L (large) 27.5< cm 828 119 143 828 119 103 828 111 183 In blue colour: 82_ 111 143 82_ 111 103 - Liner is available: - page 31. page 31. 22

Resting orthesis for knee For fixation of the knee Short-term fixation of the region of the knee following injuries and surgery SHELL (Green velour/cotton) length of the splint BASIC XXXS (children small) 36 cm 761 119 144 XXS (children large) 43 cm 762 119 144 XS (extra small) 50 cm 763 119 144 S (small) 56 cm 764 119 144 M (medium) 67 cm 766 119 144 L (large) 76 cm 768 119 144 In blue colour: 76_ 111 144 length of the splint XXXS (children small) 36 cm 761 119 104 XXS (children large) 43 cm 762 119 104 XS (extra small) 50 cm 763 119 104 S (small) 56 cm 764 119 104 M (medium) 67 cm 766 119 104 L (large) 76 cm 768 119 104 In blue colour: 76_ 111 104 Liner is available (page 31.) Resting orthesis for lower limb For fixation of the lower limb Short-term fixation of the ankle region (incl. Achilles tendon) and foot following injuries and surgery 23 SHELL length of the foot S (small) < 24.5 cm 784 119 144 M (medium) 24.5-27.5 cm 786 119 144 L (large) 27.5 < cm 788 119 144 In blue colour: 78_ 111 144 23

Reusable Chrisofix shells (ortheses) For repeated use by several patients! 90% Time Saving at Half the Cost! Time & Raw Material (costs) 100% 100% PLASTER >90% PLASTER >50% Adjustment & readjustment within one minute without water or heat Readjustment directly on the patient Transparent to X-ray The initial care of injured and/or surgically treated extremities often includes a temporary and subsequent repeated splinting or casting. For mainly economic reasons, plaster of Paris is still the most frequently used device for this purpose. The world-wide patented Swiss-Hungarian Chrisofix technology has made it possible to develop a splint line for repeat use in hospitals specialised in limb surgery. Instead of 10-15 castings, any of these orthotic devices (ankle, knee, elbow and forearm splints) can be used and reused after exchanging the liners similar to the covering sheet on an investigation table. The shells can be washed and even disinfected. The reusable shells are delivered with 5 pcs of terry-cloth liners. Additional liner is available (page 31.) 24

Volar wrist shell XXXS (children small) < 6 cm 701 317 136 XXS (children large ) 6-6.5 cm 702 317 136 XS (extra small) 6.6-7.5 cm 703 317 136 S (small) 7.6-8 cm 704 318 136 M (medium) 8.1-9 cm 706 318 136 L (large) 9< cm 708 318 136 Dorsal wrist shell XXXS (children small) < 6 cm 721 317 136 XXS (children large ) 6-6.5 cm 722 317 136 XS (extra small) 6.6-7.5 cm 723 317 136 S (small) 7.6-8 cm 724 318 136 M (medium) 8.1-9 cm 726 318 136 L (large) 9< cm 728 318 136 Palmar forearm shell length of hand XXXS (children small) <14.5 cm 711 317 136 XXS (children large) 14.5-15.5 cm 712 317 136 XS (extra small) 15.5-16.5 cm 713 317 136 S (small) 16.5-17.5 cm 714 318 136 M (medium) 17.5-19 cm 716 318 136 L (large) 19< cm 718 318 136 Palmar forearm shell with thumb support length of hand XS (extra small) <16.5 cm 73/4*3 317 139 S (small) 16.5-17.5 cm 73/4*4 318 139 M (medium) 17.5-19 cm 73/4*6 318 139 L (large) 19< cm 73/4*8 318 139 *73... right, 74...left Elbow shell elbow - finger base XXXS (children small) <20 cm 791 317 139 XXS (children large) 20-22 cm 792 317 139 XS (extra small) 22-26 cm 793 317 139 S (small) 26-30 cm 794 318 139 M (medium) 30-34 cm 796 318 139 L (large) 34< cm 798 318 139 Foot shell length of foot XXXS (children small) <18 cm 751 317 135 XXS (children large) 18-20 cm 752 317 135 XS (extra small) 20-22 cm 753 317 135 S (small) 23-24.5 cm 754 318 135 M (medium) 25-27.5 cm 756 318 135 L (large) 27.5< cm 758 318 135 Knee shell length of the splint XS (extra small) 43 cm 763 317 135 S (small) 57 cm 764 318 135 M (medium) 67 cm 766 318 135 L (large) 76 cm 768 318 135 25

CHEST ORTHESIS FOR FRACTURED RIBS IMMEDIATE PAIN REDUCTION (p<0.05) IMMEDIATE PAIN REDUCTION accelerated recovery of respiratory function reduced risk of pneumonia shorter hospitalisation breathable and waterproof properties 26

Chest orthesis/rib splint For partial fixation of the chest in case of fractured or bruised ribs S (small) 17 12 cm 604 226 104 L (large) 17 17 cm 608 226 104 SUPPLEMENTARY INFORMATION: The rib splint in the small size (S) is intended for fixing of 1-3 ribs. The chest orthesis is recommended to be used for 7-10 days. Reapplication of the same splint is not possible. The splint is waterproof and breathable. It allows showering, with care. CLINICAL STUDY REFERENCES 1. L. Zsiros, Z. Záborszky, et al.: Easy and effective method for the treatment of rib fracture by using Chrisofix -technique. 7th European Trauma Congress, Ljubljana, 2006, Int. Proceeding: 387-390. A non-randomized, placebo-controlled single-blind multicenter study on 106 hospitalized patients: the Chrisofix treated group of patients was in all assessments older and had more fractured ribs. The results are presented in the graphics below. The pain becomes significantly (p<0,05) reduced immediately after splint application Changes (ml) in the vital capacity (fvc) after admission and splint application (p<0,01) Visual Analog Scale (VAS) 0-0.5-1 -1.5-2 -2.5-3 -3.5 1h 24 h 48 h 72 h Control Chrisofix (n=18) (n=72) FVC Changes (ml) 800 600 400 200 0-200 1-2 h 24 h 48 h 72 h Time after Admission Control Chrisofix (n=12) (n=29) 2. T. Mészáros, A. Sárváry et al.: Use of chest Orthesis can significantly shorten the hospitalization of rib fracture patients. 7th European Trauma Congress, Ljubljana, 2006, Int. Proceeding: 279-282. This report includes clinical studies (a randomized and a subsequently evaluated clinical study) which were evaluated and subjected to a meta-analysis. The cause of hospitalisation of the patients was for 2-7 rib fractures. In the two studies 14 and 26 patients respectively were treated with the splint while 16 patients comprised the control groups in each of the two studies. The splinted patients were hospitalised for on average 2.2 days less than the control group. www.ribfracture.eu www.brokenribs.eu 27

Splints for First aid & Sport Injuries Seven or eight splints in a box Applicable & adjustable in seconds without water or heat Breathable First aid box with chest orthesis REFERENCE NUMBERS children 032 129 104 adults 036 129 104 First aid box without chest orthesis REFERENCE NUMBERS children 032 129 103 adults 036 129 103 28

The splints of the first aid box can be ordered even piece by piece with the following reference numbers Chest orthesis REFERENCE NUMBERS small (S) 604 226 103 Finger splint package REFERENCE NUMBERS 1 pc small (S) + 1 pc large (L) 020 127 102 Metacarpal splint - short REFERENCE NUMBERS children <7.5 cm 272 129 104 adults 7.5 < cm 276 129 104 Thumb splint IP-joint of the thumb - line of wrist REFERENCE NUMBERS children <7.5 cm 162 129 107 adults 7.5 < cm 166 129 107 Volar wrist splint REFERENCE NUMBERS children <7.5 cm 703 119 104 adults 7.5< cm 706 119 104 First aid wind-up splint REFERENCE NUMBERS wind-up splint 600x110 mm 014 022 101 wind-up splint 900x110 mm 018 022 101 wind-up leg splint 900x190 mm 046 022 101 29

ACCESSORIES EXCHANGEABLE LINERS (Liners in pack of 2 pcs) Scaphoid orthesis (S) Small 354 000 402 364 000 402 (M) Medium 356 000 402 366 000 402 (L) Large 358 000 402 368 000 402 Long metacarpal IV-V orthesis (S) Small 564 000 406 574 000 406 (M) Medium 566 000 406 576 000 406 (L) Large 568 000 406 578 000 406 De Quervain orthesis (S) Small 514 000 401 524 000 401 (M) Medium 516 000 401 526 000 401 (L) Large 518 000 401 528 000 401 CTS wrist orthesis (S) Small 334 000 405 344 000 405 (M) Medium 336 000 405 346 000 405 (L) Large 338 000 405 348 000 405 Wrist & saddle joint orthesis (S) Small 374 000 412 384 000 412 (M) Medium 376 000 412 386 000 412 (L) Large 378 000 412 388 000 412 Functional wrist & saddle joint orthesis (S) Small 644 000 402 654 000 402 (M) Medium 646 000 402 656 000 402 (L) Large 648 000 402 658 000 402 Volar orthesis (XXXS) Children small 701 000 406 (XXS) Children large 702 000 406 (XS) Extra small 703 000 406 (S) Small 704 000 406 (M) Medium 706 000 406 (L) Large 708 000 406 Dorsal orthesis (XXXS) Children small 721 000 406 (XXS) Children large 722 000 406 (XS) Extra small 723 000 406 (S) Small 724 000 406 (M) Medium 726 000 406 (L) Large 728 000 406 Palmar orthesis (XXXS) Children small 711 000 406 (XXS) Children large 712 000 406 (XS) Extra small 713 000 406 (S) Small 714 000 406 (M) Medium 716 000 406 (L) Large 718 000 406 Palmar orthesis with thumb support (XS) Extra small 733 000 409 743 000 409 (S) Small 734 000 409 744 000 409 (M) Medium 736 000 409 746 000 409 (L) Large 738 000 409 748 000 409 Elbow orthesis (XXXS) Children small 801 000 407 (XXS) Children large 802 000 407 (XS) Extra small 803 000 407 (S) Small 804 000 407 (M) Medium 806 000 407 (L) Large 808 000 407 Elbow & wrist orthesis (XXXS) Children small 771 000 407 (XXS) Children large 772 000 407 (XS) Extra small 773 000 407 (S) Small 774 000 407 (M) Medium 776 000 407 (L) Large 778 000 407 30

Club foot corrector orthesis for babies (XXXS) Children small 411 000 403 421 000 403 (XXS) Children large 412 000 403 422 000 403 (XS) Extra small 413 000 403 423 000 403 Resting orthesis for ankle & Achilles Resting orthesis for ankle & Achilles open at the Achilles tendon (XXXS) Children small 821 000 403 (XXS) Children large 822 000 403 (XS) Extra small 823 000 403 (S) Small 824 000 403 (M) Medium 826 000 403 (L) Large 828 000 403 Resting orthesis for knee (XXXS) Children small 761 000 404 (XXS) Children large 762 000 404 (XS) Extra small 763 000 404 (S) Small 764 000 404 (M) Medium 766 000 404 (L) Large 768 000 404 Exchangeable liners for reusable shells (Liners in pack of 5 pcs) Reusable volar wrist shell (XXXS) Children small 751 000 404 (XXS) Children large 752 000 404 (XS) Extra small 753 000 404 (S) Small 754 000 404 (M) Medium 756 000 404 (L) Large 758 000 404 (XXXS) Children small 701 000 206 (XXS) Children large 702 000 206 (S) Small 704 000 206 (M) Medium 706 000 206 (L) Large 708 000 206 Reusable dorsal wrist shell (XXXS) Children small 721 000 206 (XXS) Children large 722 000 206 (S) Small 724 000 206 (M) Medium 726 000 206 (L) Large 728 000 206 Reusable palmar forearm shell (XXXS) Children small 711 000 206 (XXS) Children large 712 000 206 (XS) Extra small 713 000 206 (S) Small 714 000 206 (M) Medium 716 000 206 (L) Large 718 000 206 Reusable palmar shell with thumb support (XS) Extra small 733 000 209 743 000 209 (S) Small 734 000 209 744 000 209 (M) Medium 736 000 209 746 000 209 (L) Large 738 000 209 748 000 209 Reusable elbow & wrist shell (XXXS) Children small 791 000 209 (XXS) Children large 792 000 209 (XS) Extra small 793 000 209 (S) Small 794 000 209 (M) Medium 796 000 209 (L) Large 798 000 209 Reusable resting shell for ankle & Achilles (XXXS) Children small 751 000 205 (XXS) Children large 752 000 205 (XS) Extra small 753 000 205 (S) Small 754 000 205 (M) Medium 756 000 205 (L) Large 758 000 205 Reusable resting shell for knee (XS) Extra small 763 000 205 (S) Small 764 000 205 (M) Medium 766 000 205 (L) Large 768 000 205 31

Combines the advantages of ortheses and cast-like (e.g. POP) fixations In contrast to the conventional ortheses (segmental fixations), the Chrisofix product range ensures stable semicircular or circular fixation, can be adjusted and readjusted in seconds, can be adjusted directly on to the patient, has opened up new horizons in the usage and benefits of therapeutic splinting, can provide more targeted immobilisation. In contrast to the cast-like fixations, the Chrisofix products cut down the costs, can be adjusted without water or heat in seconds, saving time for the clinical personnel and the patients, can allow more convenient daily hygiene and an earlier start of physiotherapy, can replace most of the thermoplastic fixations, are light and comfortable similarly to the usual ortheses, can repeatedly be adjusted for the same patient, in case of Reusable Shells they can be readjusted and reused by several patients after disinfection and exchange of the liner. Manufacturer: CHRISOFIX AG. CH-8201 Schaffhausen, P.B. 3028 Tel: 00-41-52-670 1160 info@chrisofix.ch www.chrisofix.ch ORKRISZ Patented Production (EN ISO 13485:2012): ORKRISZ Kft. H-1239 Budapest, Grassalkovich út 272-274. Tel.: 00-36-1-287 1056 Fax: 00-36-1-289 0232 info@orkrisz.hu www.orkrisz.hu 2017 10