Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-01-31

Brief Summary

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This is a phase III, randomised controlled trial of matrix-encapsulated chondrocyte implantation procedure compared to the microfracture procedure in the repair of symptomatic cartilage lesions of the knee. Eligible patients were asked for informed consent preoperatively and randomised for chondrocyte implantation of microfractures. Those patients allocated to the chondrocyte implantation group will be harvested at time of first arthroscopic procedure and concurrent lesions were treated, as meniscus repair, ligament reconstruction, or malalignment corrected. The patients allocated to microfracture will be treated at the time of the only arthroscopic procedure. Both groups will have the same rehabilitation program. Prospective clinical, radiographic and magnetic resonance imaging will be performed as main outcomes.

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Detailed Description

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Conditions

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Tear; Knee, Cartilage, Articular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Chondrocyte implantation

From a previous biopsy, articular cartilage matrix is digested and chondrocytes are cultured in 2 passages until implants with at least 6,000,000 cells are constructed. These constructus of 8 mm in diameter are implanted arthroscopically by means of biodegradable anchor (MINILOK QUICKANCHOR TM from DePuy-Mitek ) located at the defect and tied securely.

Group Type EXPERIMENTAL

Matrix encapsulated chondrocyte implantation

Intervention Type PROCEDURE

Each implant contains 6,000,000 autologous chondrocytes.

Microfractures

Subchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area.

Group Type EXPERIMENTAL

Microfracture awl

Intervention Type PROCEDURE

Is an awl that allow perforation of the subchondral bone.

Interventions

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Matrix encapsulated chondrocyte implantation

Each implant contains 6,000,000 autologous chondrocytes.

Intervention Type PROCEDURE

Microfracture awl

Is an awl that allow perforation of the subchondral bone.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with symptomatic single chondral lesions of the knee from 1 to 4 cm2.
* Signed patient informed consent.
* Agree to adhere to rehabilitation protocol.

Exclusion Criteria

* Inflammatory arthritis, septic arthritis, gout, pseudogout, Paget's disease, ochronosis, acromegaly, hemochromatosis, tumors, collagen mutations.
* Total meniscectomy
* Malalignment
* Evidence of osteoarthritis

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No