Articular cartilage repair using collagen type I hydrogels Clincal results

Transcription

1 Articular cartilage repair using collagen type I hydrogels Clincal results Ulrich Nöth, MD Department of Orthopaedic Surgery, König-Ludwig-Haus University of Würzburg, Germany Orthopädisches Zentrum für Muskuloskelettale Forschung (OZMF) OZMF

2 ACI techniques ACI techniques a) 1st generation classical ACI (Brittberg and Peterson, 1994) - hypertrophy periostal flap - not posterior condyle/ tibia plateau b) 2nd generation matrix-based ACI different matrices - collagen I/III membrane - hyaluronic acid sponge - PLA/collagen sponge - hydrogel (collagen type I) - etc

3 Membrane vs hydrogel membrane hydrogel + homogeneous cell distribution homogeneous ECM-production + viscoelastic properties similar to hyaline cartilage Sittinger et al., 2000 Nöth et al., 2010

4 Collagen type I hydrogel Cartilage Repair System (CaReS) collagen type I hydrogel (rat tail) since 2003 in clinical use over 2000 procedures all defects at the knee joint (condyle, patella, tibia, chondral/osteochondral)

5 Transplant fabrication biopsy (arthroscopically) collagen digestion chondrocyte suspension mix with collagen I gel pour in 6 well-dishes (final concentrationn of col I: 3 mg/ml) cultured for 12 days 8 mm thick (normally) advantages: + no cultivation in monolayer + less dedifferentiation (Schneider et al., 2004)

6 Implantation technique

7 Defect types I. condyle II. trochlea III. tibia IV. osteochondral defect V. patella VI. multiple lesions

8 Case # 1 Osteochondral defect 31 yr male

9 Case # 1 Osteochondral defect 31 yr male

10 Case # 1 Osteochondral defect 31 yr male

11 Case # 1 Osteochondral defect 3 months postop

12 Case #2 Patella (no cartilage shoulder) 33 yrs male

13 Case #2 Patella (no cartilage shoulder) 33 yrs male

14 Case #3 Patella (no cartilage shoulder) 33 yrs male

15 Case #2 Patella (no cartilage shoulder) 33 yrs male

16 Case #2 Patella (no cartilage shoulder) 33 yrs male

17 Patella - additional procedures - Lateral release Osteotomy tibial tuberosity Osteotomy femur

18 Case #3 Multiple lesions 29 yrs male

19 Case #3 Multiple lesions 29 yrs male

20 Histology 1 year U. Schneider, MD (University of Aachen)

21 Multicenter study 2003 to 2008 prospective multicenter study 6 centers n =116 patients min. follow-up of 12 months max. follow-up of 60 months mean follow-up 30.7 months IKDC- score, pain, SF-36, doctor/patient satisfaction, IKDC functional status Inclusion criteria (according to ICRS) intact corresponding cartilage (max. ICRS grade II) intact meniscus (2/3 intact) intact ligaments (if not = repair) defect size up to 10 cm2 regular alignment (if not = correction of axis) free ROM BMI less than 30 closed epiphysis max. age 50 years Exclusion criteria joint infection OA, RA HIV, hepatitis diabetes

22 Patient data Diagnosis n 25.3 age 32.8 years Cartilage surgery before ACI 56.9% ACL, meniscus, osteotomy before ACI 25% Previous surgery 81.9% defect side BMI size 42% female, 58% male number gender OD 43 (37,0%) Trauma/degenerative 73 (63,0%) < 4 cm 2 39 (33,6%) > 4 cm 2 77 (66,3%) Medial condyle 77 (66,4%) Lateral condyle 17 (14,7%) Patella/trochlea 22 (18,9%) Single 106 (91,4%) Multiple 10 (8,6%)

23 Additional surgery ACL-repair n=8 Meniscus surgery n=7 Bone grafting n =11 Osteotomy n=8

24 Rehabilitation program isolated femoral and tibial defects immobilization for 48 hours in a brace locked at 10 flexion flexion: 30 during the first 3 weeks 60 for another 3 weeks partial weight bearing for 12 weeks (15 kg for 6 weeks and 30 kg for the following 6 weeks) reconstruction of the subchondral bone: no weight bearing for 6 weeks patella or trochlea groove immobilization in 30 flexion for 48 hours flexion: 30 to 90 for three weeks full weight-bearing after 48 hours

25 preop 3 months 6 months 12 months 24 months 36 months 48 months 60 months Follow-up (30,7 months) n Mean 42,2 47,3 59,3 68,7 70,4 70,7 68,8 73,2 70,5 SD 13,8 16,2 18,0 17,5 19,2 15,1 18,3 15,8 18,7 Min Max IKDC-Score

26 IKDC-Score p<0,001, d=1, p=0,004, d=0,34 p<0,001, d=0,68 p<0,001, d=0,54 90 p=0,247, d=0,22 p=0,004, d=0, ± ± ± ± ± ± MW SD 73,15 73, er at iv el y Pr eo p 73,15 85,83 87,10 88,95 M m on taht se 60 Monate 86,23 89, ,43 70,73 68,84 M m on taht se 70,43 70,73 68, Monate 48 Monate 70,43 70,73 68,84 12 Monate 024 Monate 63,44 77,35 M m on taht se 59,35 68, ,35 68,72 56,12 M m on taht se 59,35 68,72 3 Monate 106 Monate M m on taht se 42,36 47,29 M m on taht se 42,36 47, SD 42,36 47,29 M m on taht se MW 20Preoperatively 66. p=0,115, d=0, ± ± IKDC Means Score p=0,510, d=0,00 preop 3 months 6 months 12 months 24 months 36 months 48 months 60 months Follow-up (30,7 months) n Mean 42,4 47,3 59,3 68,7 70,4 70,7 68,8 73,2 70,5 SD 13,8 16,2 18,0 17,5 19,2 15,1 18,3 15,8 18,7 Min Max IKDC-Score

27 * * * *

28 Pain (VAS) * * *

29 SF-36 health survey

30 Doctor/patient satisfaction doctor: 88% very good and good results patient: 80% very good and good results

31 ICRS functional knee status 4-point scale 23.4% unlimited function (status I) 56.3% minor limitations (status II) 17.2% eminent limitations (status III) 4.1% maximal limitation (status IV) patient: 79.7% very good and good results

32 Complications Transplant n = 6 2 x no sufficient cell number (second biopsy) 1 x transplant shrinking (second biopsy) 3 x implant damage during operation (second implant) re-arthroscopy/symptoms n=7 2 x transplant hypertrophy 1 x insufficient coverage 1 x plicasyndrom 2 x synovitis 1 x hydrops after ACL- replacement Effussion longer than 6 months n = 5 (2 x after trauma) all disappeared after 12 months Infection/neuro/allergy n=4 1 x bursitis (E. faecalis, antibiotics) 1 x haematoma 1 xneurinoma 1 x allergy to suture material

33 Summary CaReS- technology is a safe procedure IKDC IKDC 70.5 in 116 patients after 30.7 months plateau after 12 months diagnosis: significant better results in OD vs degenerative/trauma Pain (VAS) reflects the IKDC outcome together with IKDC very important outcome parameter SF-36 increase of the physical and mental component

34 Summary Patient doctor satisfaction doctor: 88% very good and good results patient: 80% very good and good results (BIAS?) ICRS functional knee status patient: 79.7% status I and II reflects patient satisfaction (80%) results are comparible with other matrix-based technologies using membranes or sponges

35 Thank you Co-authors Univ.- Würzburg Rackwitz, Siebenlist, Fensky, Barthel, Eulert, Rudert Participating centers Zeichen, Fickert, Bohnsack, Steinhagen, Tibesku, Specht, Andereya, Loeer, Glahn, Zinser, Grossstück, Fischer, Schneider