Evaluation of matrix-associated autologous chondrocyte transplantation as treatment of cartilage lesions of the knee joint

Phase 1

• Conditions: Cartilage lesion; MedDRA version: 18.0Level: LLTClassification code 10072638Term: Articular cartilage defectSystem Organ Class: 100000004859; MedDRA version: 18.0Level: LLTClassification code 10064113Term: Cartilage allograftSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-003584-11-AT
• Lead Sponsor: Medical University Innsbruck

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-04
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

- Grade four chondral or osteochondral lesion of the knee joint, treated with MACT
- Defect size > 2cm²
- Patient age at the date of follow up: 18-65 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

- Patient age at the date of follow up < 18 or > 65 years
- Current history of knee instability
- Malalignment (varus/valgus = 5° and not corrected during surgery or despite correction)
- Previous surgeries or injuries to the hyaline cartilage of the affected knee joint
- Congenital malformation of the lower extremity
- Medical secondary diagnosis which could influence cartilage metabolism
- Medical therapies which could influence cartilage metabolism
- Secondary diagnosis (e.g. neurological) which could influence physiological weight bearing
- Contraindication to MRI
- Patient is not able to obtain informed consent due to physical or mental disability
- Patient has no legal capacity

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the clinical and radiological outcome (MRT) after MACT and to correlate these findings with the initial cell count of the chondrocyte graft. What is more, further knowledge about additional factors influencing the outcome of the surgery may be gained. This pilot study could provide valuable data for the design of a prospective randomized clinical trial.;Secondary Objective: Localization of the lesion (medial/lateral femural condyle, patella, trochlea)<br>Age and sex<br>Lesion size;Primary end point(s): -Clinical outcome: Short Form 36 (SF-36), WOMAC, IKDC<br>-Radiological outcome: MOCART-Score assessed on MRI <br>-Initial cell count of the chondrocyte graft (f.e. according to the report of Novocart 3D-XL, or as available)<br>;Timepoint(s) of evaluation of this end point: 5-9 years after surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Localization of the lesion (medial/lateral femural condyle, patella, trochlea)<br>-Age and sex<br><br>;Timepoint(s) of evaluation of this end point: 9 years after Initial surgery.