Symptomatic cartilage defects in the knee Musculoskeletal Diseases Arthritis
Conditions
Interventions
According to the treatment allocation, trial participants will receive one of the three following cell therapy strategies:
1. Autologous chondrocytes:
1.1. One syringe containing resuspended autologou
Sponsors
Robert Jones and Agnes Hunt Orthopaedic Hospital (UK)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. A symptomatic defect of the knee that extends to (Outerbridge grade 4) or into the subchondral bone 2. The patient will be aged between 18 and 80 years at the time of surgery 3. The defect is considered suitable for ACI 4. Surgical treatment has been performed on the same defect at least 6 months previously and has failed to relieve symptoms 5. The patient is able to provide written informed consent to participate in the trial
Exclusion criteria
Exclusion criteria: 1. English is not the first language of the patient 2. Likely to show contraindications to autologous cell therapy: 2.1. Osteoarthritis 2.2. Inflammatory arthritis 2.3. Previous or current malignant tumour 2.4. Therapy with steroids or methotrexate 2.5. Bleeding tendency or known anaphylaxis to any product used in chondrocyte preparation 3. Low probability of compliance with physiotherapy or follow-up, including a major life threatening condition 4. A defect of greater than 20cm2 in total area 5. The patient is shown to be positive for serology tests required by the cell provider. This includes: 5.1. HIV 5.2. Hepatitis B and C 5.3. Syphilis 5.4. Human T cell lymphotrophic virus (HTLV) I & II 6. Pregnancy or lactation 7. Exclusion criteria (5) and (6) will not be confirmed until after written informed consent is obtained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported functional knee score (Modified Lysholm) at 15 months, taking into account the pre-operative score as a covariate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events 2. Quality of the repair tissue determined using the Oswestry Arthroscopy Score, for which participants will undergo a repeat arthroscopy between 12 and 15 months 3. A 2mm diameter needle biopsy will also be taken at this time, and the histology analysed by a blinded assessor using the International Cartilage Repair Society (ICRS) II histology scoring system 4. An MRI/CT scan will also be performed, with the participants' agreement, and scored by a blinded assessor using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score 5. Health related quality of life, pain, knee function, activity levels and general mood of the patient will be assessed at 2m, 12m, 15m and annually up to 20 years post treatment using the following scores respectively: 5.1. The Veterans Rand 12 Item Health Survey (VR-12) 5.2. the Intermittent and Constant Osteoarthritis Pain score (ICOAP) 5.3. KOOS physical function short form (KOOS-PS) 5.4. Modified Lysholm Score 5.5. Human Activity Profile (HAP) 5.6. International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) 6. Number of years free from further surgery 7. Observed patterns of rehabilitation and compliance to physiotherapy schedules will be collected using a participant diary up to 15 months post treatment 8. Unit costs per treatment will be recorded in order to perform a cost utility analysis | — |
Countries
England, United Kingdom
Outcome results
None listed