Autologous Cartilage Implantation vs Arthroscopic Debridement

NCT02636881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-09-25

No results posted yet for this study

Summary

82 patients aged 18-49 years with an isolated focal cartilage defect in the knee will be randomized to either receive autologous cartilage implantation or arthroscopic debridement. Both groups will then undergo a systematic physiotherapy training regime for 6-9 months. The Groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D (European Quality of Life 5 dimensions) as well as clinical examination and radiological findings at 2 years (MRI).

Conditions

  • Knee Injury
  • Cartilage Injury

Interventions

PROCEDURE

Autologous Chondrocyte Implantation

Implantation of the patients own cartilage cells in a chondral defect of the knee

PROCEDURE

Arthroscopic Debridement

Arthroscopic diagnosis and debridement of the lesion, without cartilage therapy. Removal of lose bodies etc.

Sponsors & Collaborators

  • University Hospital, Akershus

    lead OTHER

Principal Investigators

  • Heidi Hanvold, PT · Research coordinator

  • asbjørn Årøen, MD, PhD · Akerhus University hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Norway

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02636881 on ClinicalTrials.gov