Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

Matrix-encapsulated Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures for Articular Cartilage Regeneration. Randomised Clinical Trial.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01947374

Enrollment

Registered

2013-09-20

Start date

2010-01-31

Completion date

2015-01-31

Last updated

2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tear; Knee, Cartilage, Articular

Keywords

Cartilage, Articular

Brief summary

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.

Interventions

PROCEDUREMatrix encapsulated chondrocyte implantation

Each implant contains 6,000,000 autologous chondrocytes.

PROCEDUREMicrofracture awl

Is an awl that allow perforation of the subchondral bone.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
MRI T2 Mapping	24 months	Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.

Secondary

Measure	Time frame	Description
Clinical evaluation	0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months	Clinical assessment with validated knee scores, and adverse effects register are taken.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026