Orthopaedics Musculoskeletal Diseases Chondral defect(s) in the knee
Conditions
Interventions
Arm 1: Autologous chondrocyte implantation (ACI)
Arm 2: One 'conventional' treatment chosen by surgeon/ patient from following list: Debridement
Abrasion
Microfracture
Mosaicplasty.
Arm 1 (ACI) is further randomised to receive a patch made from either:
a) Periosteum or
b) Collagen membrane
Sponsors
Keele University (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 09/11/2012: 1. Symptomatic chondral defect(s) on the medical or lateral femoral condyle, trochlea or patella suitable for either ACT or one of the existing conventional treatments (debridement, abrasion, drilling, microfracture, mosaicplasty) 2. Surgical treatment for the same defect carried out at least 12 months previously, that has not relieved symptoms 3. Not more than two defects, not kissing and total area not greater than 12cm2 4. Likely to comply with appropriate physiotherapy Previous inclusion criteria until 09/11/2012: 1. Symptomatic chondral defect(s) on the medical or lateral femoral condyle or trochlea suitable for either ACT or one of the existing conventional treatments (debridement, abrasion, drilling, microfracture, mosaicplasty) 2. Surgical treatment for the same defect carried out at least 12 months previously, that has not relieved symptoms 3. Not more than two defects, not kissing and total area not greater than 12cm2 4. Likely to comply with appropriate physiotherapy
Exclusion criteria
Exclusion criteria: 1. Concurrent meniscectomy/osteotomy or untreated malalignment of patella 2. Generalised osteoarthritis, inflammatory condition or history of mesenchymal tumors 3. Patient in different clinical trial involving the knee, currently or in last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to cessation of benefit: as defined when 2/3 assessment criteria show no improvement compared to preoperative assessment levels at least 12 months after surgery: 1. Independently assessed Lysholm Knee score 2. Patient self-assessed Lysholm Knee questionnaire 3. Independent assessor's judgement based on impact on quality of life, physical examination and functional observation | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Norway, United Kingdom
Outcome results
None listed