EVIDENCE BASED MEDICINE. Pennig Dynamic Wrist Fixator

Transcription

1 EVIDENCE BASED MEDICINE Pennig Dynamic Wrist Fixator I

2 1.PRODUCT OVERVIEW Orthofix approach to Evidence Based Medicine For years, clinical decision-making was based primarily on physician knowledge and expert opinion. Now, the medical community is searching for measurable outcomes validating efficacy of treatments. Evidence Based Medicine (EBM) is an approach that integrates individual clinical expertise with the best available evidence when making decisions about patient treatment. (Nierengarten MB et al. Using Evidence Based Medicine in Orthopaedic Clinical Practice: The Why, When, and How-To Approach. Medscape Orthopaedics & Sports Medicine. 2001; 5[1]). Over the last few years, there has been a significant growth in Evidence Based Medicine. DISCLAIMER This document is designed as a scientific tool for surgeons. As such, it reviews medical literature focusing on the Pennig Dynamic Wrist Fixator with the specific aim to collect scientific evidence on the performance of the system, as published by independent studies. This document is not intended to substitute the instructions for use (leaflet), nor any product claims can be taken from it. For information and guidelines for its correct use please refer to the "Pennig Dynamic Wrist Fixator" operative techniques. To receive a digital copy of this Voice of Literature please submit your request to: CLINICAL AFFAIRS DEPT: clinicalaffairs@orthofix.com Phone: To receive a digital copy of the Operative technique, please submit you request to: INTERNATIONAL MARKETING DEPT: intlmarketing@orthofix.com Phone: Voice of Literature

3 1.PRODUCT OVERVIEW INDEX 1. PRODUCT OVERVIEW p LITERATURE APPRAISAL & REVIEW p References 2.2 Methodological evaluation 2.3 Demographic details 2.4 Results 2.5 Conclusions 3. A COMPARISON BETWEEN... p. 9 PLASTER CAST AND PENNIG DYNAMIC WRIST FIXATOR IN THE TREATMENT OF OSTEOPOROTIC DISTAL RADIAL FRACTURES 4. FURTHER READINGS p. 12 1

4 1.PRODUCT OVERVIEW The Pennig Dynamic Wrist Fixator is a highly stable, light-weight fixator for distal radial fractures, with double ball joints that allow fracture reduction in all planes with the fixator applied. Its main features are as follows: * Transarticular dynamic frame for early motion * Non-bridging extra-articular frame * Extra-articular frame for corrective osteotomies * Ulna outrigger for ulnar instability * Double ball joint for multiplanar ligamentotaxis * Radiolucent extra-articular module for fracture visualization * Highest quality instrumentation The Pennig Dynamic Wrist Fixator can be used for unstable extra-articular or intra-articular fractures. When used in the transarticular mode, ligamentotaxis can be employed to assist in fracture reduction. When desired, flexion-extension of the wrist joint can be allowed without displacement of fracture fragments. In most severe fractures supplementary techniques are needed to improve stability (e.g. bone graft, FFS, K-wires). The extraarticular application allows unrestricted motion from day one and improved patient function during treatment. The radiolucent clamp allows unhampered visualization of the reduction and variable pin placement in the distal fragment. The Pennig Dynamic Wrist Fixator provides better reduction of distal radial fractures, leading to improved functionality of the wrist joint. This category of fixator facilitates restoration of radial length, volar tilt, and carpal alignment; improves the grip strength; and allows greater range of motion even during early rehabilitation. Owing to early mobilization of the wrist joint with the use of the Pennig Dynamic Wrist Fixator, many conditions such as joint stiffness and circulatory disorders can also be prevented. For further information on its components and guidelines for its use, please refer to the following documents: * Brochure: Pennig Dynamic Wrist Fixator - PBWRI E0 * Quick Ref. Guide: The Pennig Dynamic Wrist Fixator - Trans-Articular Application - PG10A * Quick Ref. Guide: The Pennig Dynamic Wrist Fixator - Extra-Articular Application - PG10B Voice of Literature

5 2. LITERATURE APPRAISAL & REVIEW The Pennig Dynamic Wrist Fixator improved the efficacy of the previous Pennig I Wrist Fixator, without modifying its clinical applications. We can therefore assume that its performance is equivalent or better than that reported in medical literature focusing on the Pennig I Wrist Fixator. This is why the following analysis of clinical literature, aimed to proof the product performance, comprises articles focused on the Pennig Dynamic Wrist Fixator and the Pennig I Wrist Fixator. 2.1 REFERENCES 1. Redisplaced unstable fractures of the distal radius: a prospective randomized comparison of four methods of treatment. McQueen MM, Hajducka C, Court-Brown, CM. J Bone Joint Surg Br (1996) 78(3): Redisplaced unstable fractures of the distal radius. A randomized, prospective of bridging versus non-bridging external fixation. McQueen MM. J Bone Joint Surg Br (1998) 80(4): Treatment of type C3 distal radius fracture resulted from high-energy by volar plate in combination with external fixator. Zhang QL, Zhu XD, Li GD, Tang H, Li M, Wu DJ. Chi Med J [Engl] (2009) 122(13): Cast vs external fixation: a comparative in elderly osteoporotic distal radial fracture patients. Moroni A, Vannini F, Faldini C, Pegreffi F, Giannini S. Scand J Surg (2004) 93(1): Die Behandlung instabiler distaler radiusfrakturen mit einem transarticularen fixateur externe. Ergebnisse einer Langzeitbeobachtung. Joosten U, Joist A, Frebel T, Rieger H. Chirurg (1999) 70: Results of transarticular fixator application in distal radius fractures. Klein W, Dee W, Rieger H, Neumann H, Joosten U. Injury (2000) 31(Suppl. 1): Clinical results of external fixation for unstable Colles' fractures. Yamamoto K, Masaoka T, Shishido T, Imakiire A. Hand Surg (2003) 8(2): Fracture treatment in children data analysis and follow-up results of a prospective. Bennek J, Buhligen U, Rothe K, Muller W, Rolle U, Giec T, Bennek C. Injury (2001) 32 (Suppl. 4): SD The use of external fixation in complex trauma of upper limb. Corain M, Carità E, Vassia L. Chir Organi Mov (2008) 91(1): Reduction techniques in distal radius fractures. Dée W, Klein W, Rieger H. Injury (2000) 31:

6 LITERATURE APPRAISAL & REVIEW 2.2 METHODOLOGICAL EVALUATION CRITERIA McQueen [1] McQueen [2] Zhang [3] Moroni [4] Joosten [5] Inclusion and exclusion criteria defined 2 RCT or prospective Klein [6] Yamamoto [7] Bennek [8] Corain [9] Dée [10] 3 Clear primary outcome Evaluated endpoints Adequate sample size Consistent follow-up times ( 3 months) Complete follow-up >80% Statistical analysis International peer reviewed journal Publication year (last 5 years) Score WEAK MEDIUM STRONG Voice of Literature

7 LITERATURE APPRAISAL & REVIEW 2.3 DEMOGRAPHIC DETAILS Author Design Population No. of patients Treatment Follow-up McQueen [1] Prospective Av. age: 63 (16 to 86) years Females: 89% 120 patients Group 1: 30 Group 2: 30 Group 3: 30 Group 4: 30 Group 1: Closed re-reduction Group 2: Open reduction Group 3: Closed re-reduction + Pennig wrist fixator Group 4: Closed re-reduction + Pennig wrist fixator with the ball joint release after 3 weeks 12 months McQueen [2] Prospective Av. age: patients (31 to 85) Group I: 30 years Group II: 30 Females: 91.6% Group I: Closed re-reduction + Pennig external fixator Group II: Closed reduction + non-bridging Pennig wrist fixator 12 months Zhang [3] Moroni [4] Retrospective Prospective randomized trial Av. age: 37 (26 to 47) years Females: 36.6% Age: 65 years Females: 100% 30 patients Pennig wrist fixator 18 months* (range: months) 40 patients Group A: Plaster cast Group B: Pennig Dynamic wrist fixator 3 months Joosten [5] Klein [6] Yamamoto [7] Bennek [8] Corain [9] Prospective Prospective Retrospective Prospective Retrospective Av. age: (15 to 88) years Females: 47.7% Av. age: 48 (12 to 89) years Females: 45% 174 patients Pennig wrist fixator 28.5 months* (range: months) 102 patients Pennig wrist fixator 20.3 months* Av. age: patients (12 to 89) Group A: 35 wrists years Group B: 57 wrists Females: 45.4% Av. age: 9.3 (0.9 to 17.3) years Females: 30.3% 389 patients 1 distal radius fracture Av. age: patients years 11 wrists fractures Females: 18.1% Group A: Pennig wrist fixator + Non-early motion Group B: Pennig wrist fixator + Early motion Pennig wrist fixator Pennig wrist fixator Range: 6 50 months 98 months 44.7 months* (range: months) Dée [10] Retrospective Not available 22 patients Pennig wrist fixator 6 months *Average follow-up period 5

8 LITERATURE APPRAISAL & REVIEW 2.4 RESULTS *McQueen [1] Group 1 Group 2 Group 3 Group 4 Mass grip strength (%) Flexion (%) Extension (%) McQueen [2] Group I Group II Zhang [3] *McQueen [1] reported average values of flexion and extension. All values are expressed as percentage of the controlateral side at the end of the follow-up period. Overall Functionality Moroni [4] Group A Group B Corain [9] Horesh demerit point = 7.7; SF-36 score = 66.2/100 Horesh demerit point = 6.6; SF-36 score = 67.1/100 Patient's satisfaction score = 5.9/8.0 Excellent Good Satisfactory/fair Poor *Klein [6] **Yamamoto [7] *41% *46% *10% *3% 72.8% 22.8% 3.3% 1.1% *Gartland & Werley score. **Demerit scoring system used in Colles fractures. Functional bracing in supination. Sarmiento A, Pratt GW, Berry NC, Sinclair WF. J Bone Joint Surg Am 1975 Apr; 57 (3): Voice of Literature

9 LITERATURE APPRAISAL & REVIEW Complications McQueen [1] Group 1: 3% reflex sympathetic dystrophy, 3% carpal tunnel syndrome Group 2: 3% pin-track/k-wire infection, 7% wound infection Group 3: 23% pin-track/k-wire infection, 3% dorsal medial neurapraxia Group 4: 7% pin-track/k-wire infection, 7% carpal tunnel syndrome McQueen [2] Group A: 6.6% (2 cases) pin-track/k-wire infection, 6.6% reflex sympathetic dystrophy Group B: 23.3% (7 cases) pin-track/k-wire infection, 6.6% extensor pollicis longus rupture Zhang [3] 16.6% pin-track/k-wire infection (5 cases), 10% traumatic arthritis (3 cases) Joosten [5] 0.6% algodystrophy, 0.6% fixator dislocation, 0.6% break-out of pin from metacarpal bone Klein [6] 1% reflex sympathetic dystrophy, 1% wire loosening/breakage, 5% fixator displacement Yamamoto [7] 1 case of paralysis of the median nerve 7

10 LITERATURE APPRAISAL & REVIEW 2.5 WHAT THE AUTHORS SAY... CONCLUSIONS In our experience, external fixation of unstable distal radius fractures is a successful tool. The main complication of displacement of the fixator was not seen after modification of the double-ball joint The possibility of mobilization of the fixator after approximately 3 weeks is an option in the system. KLEIN [6] Non-bridging external fixation achieves a better reduction of unstable distal radial fractures than the bridging method and this is maintained at one year. It restores carpal alignment, achieves a significantly better grip strength and the range of movement is significantly increased, especially in the early period of rehabilitation. The key to the improved results is the ability of non-bridging external fixation to regain and maintain the normal volar tilt, allowing correction of the carpal alignment which is significantly related to better functional outcome Non-bridging external fixation is a significantly better technique than bridging both anatomically and functionally and is the treatment of choice for unstable fractures of the distal radius in which external fixation is contemplated and there is sufficient space in the distal fragment. MCQUEEN [2] In our department, we use the Pennig external fixator, a type of mobile external fixator. Although the Pennig external fixator is light in weight, it is characterized by an excellent fixative power, a large degree of freedom due to the presence of double ball joints, and strong traction power due to the presence of a distraction bar. Therefore, the Pennig external fixator is useful for reducing various types of fractures. YAMAMOTO [7] Limb alignment and length maintenance, respect of soft tissues, short assembly times, versatility and simple application make EF (external fixation) helpful in the management of these complex traumas. CORAIN [9] We recommend external fixation of distal radius fractures using three-dimensional ligamentotaxis as a minimally-invasive technique to gain anatomical reduction in unstable distal radius fractures. DÉE [10] Voice of Literature

11 3. A COMPARISON BETWEEN... PLASTER CAST AND EXTERNAL FIXATION WITH ORTHOFIX PENNIG DYNAMIC WRIST FIXATOR BEARING HYDROXYAPATITE-COATED PINS IN THE TREATMENT OF OSTEOPOROTIC DISTAL RADIAL FRACTURES 1. Cast vs external fixation: a comparative in elderly osteoporotic distal radial fracture patients. Moroni A, Vannini F, Faldini C, Pegreffi F, Giannini S. Scand J Surg (2004) 93: STUDY DETAILS Patients: Fracture type: Total No. of patients: Gender: Age: Treatment: Osteoporotic distal radial fracture patients AO type A2 or A3 40 Female 65 years Group 1: Plaster cast Group 2: Orthofix Pennig Dynamic Wrist Fixator 20 patients 20 patients 3.2 RESULTS FIGURE 1 VOLAR ANGLE Volar angle (degree) Preoperative Postoperative 6 weeks 12 weeks Plaster cast Pennig Dynamic Wrist Fixator 9

12 A COMPARISON BETWEEN... FIGURE 2 RADIAL ANGLE Radial angle (degree) Preoperative Postoperative 6 weeks 12 weeks Plaster cast Pennig Dynamic Wrist Fixator Redisplacement of volar (p < ) and radial (p = 0.008) angle was significantly lower in the Pennig Dynamic Wrist Fixator group. FIGURE 3 RADIAL SHORTENING (mm) 12 weeks weeks Postoperative Preoperative Radial Shortening (mm) Plaster cast Pennig Dynamic Wrist Fixator Voice of Literature

13 A COMPARISON BETWEEN... OTHER ENDPOINTS - Horesh Demerit point system score was 7.7 ± 3.3 for the plaster cast group and 6.6 ± 3.4 for the Pennig Dynamic external fixator group (p < 0.006). - SF-36 mean score was 66.2 ± 13.1 points for the plaster cast group and 67.1 ± 13.1 points for the Pennig Dynamic external fixator group. 3.3 COMPLICATIONS - In the plaster cast group, 4 redisplacements (volar angulation exceeding or radial shortening of more than 3 mm) occurred, whereas in the Pennig Dynamic external fixator group, there were none (p = 0.005). - No pin loosening and infection occurred in the Pennig Dynamic external fixator group. 3.4 CONCLUSIONS: What the authors say - Both radiographic and clinical results were better in the external fixation group than in the plaster cast group. - At the follow up, the external fixator group was found on average to have better correction. - Our supports the use of external fixation in the treatment of osteoporotic wrist fractures. 11

14 4. FURTHER READINGS The following articles have not been analyzed as they pertain to case reports, review and operative technique description, cadaveric studies and biomechanical studies which are not applicable to our scoring system used for the article evaluation. Single case report: - Salvage of upper limb following a severe crushing trauma: immediate reconstruction with a free flap and subsequent hyperbaric oxygen therapy. Serra MP, Longhi P. Case Report Med (2009) Review and operative technique description: - Principles of external fixation and supplementary techniques in distal radius fractures. Gausepohl T, Pennig D, Mader K. Injury (2000) 31 (Suppl. 1): The treatment of severely comminuted intra-articular fractures of the distal radius. Mader K, Pennig D. Strat Traum Limb Recon (2006) 1: Corrective osteotomies in malunited distal radius fractures: external fixation as one stage and hemicallotasis procedures. Pennig D, Gausepohl T, Mader K. Injury (2000) 31 Suppl 1: Dynamic external fixation of distal radius fractures. Pennig DW. Hand Clin (1993) 9(4): External fixation of the wrist. Pennig D, Gausepohl T. Injury (1996) 27(1): Cadaveric : - Extraarticular external fixation in distal radius fractures pin placement in osteoporotic bone. Gausepohl T, Worner S, Pennig D, KoebkeInjury J. Int J Care Injured 32 (2001) S-D-79 S-D-85. Biomechanical : - Biomechanical characteristics of nonbridging external fixators for distal radius fractures. Yamako G, Ishii Y, Matsuda Y, Noguchi H, Hara T. J Hand Surg (2008) 33A: Voice of Literature

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16 Manufactured by: ORTHOFIX Srl Via Delle Nazioni Bussolengo (Verona) Italy Distributor: Telephone Fax Voice of Literature Pennig Dynamic Wrist Fixator Voice of Literature www. orthofix. com PG-1201-VOL-E0 A 05/12