NCT02636881

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

6.4 years

First QC Date

December 14, 2015

Last Update Submit

September 23, 2024

Conditions

Knee InjuryCartilage Injury

Outcome Measures

Primary Outcomes (1)

  • The Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life

    The KOOS is a validated patient oriented outcome measure validated to use in cartilage Research. It assesses five domains, and the Fifth domain (knee related quality of life) will be the primary endpoint in this study.

    up to 24 months

Secondary Outcomes (8)

  • The Knee Injury and Osteoarthritis Outcome Score (KOOS) Other domains

    preop, 3, 6, 12 and 24 months.

  • Tegner Score

    preop, 3, 6, 12 and 24 months.

  • Lysholm Knee Score

    preop, 3, 6, 12 and 24 months.

  • EQ5D

    preop, 3, 6, 12 and 24 months.

  • Visual Analogue Scale

    preop, 3, 6, 12 and 24 months.

  • +3 more secondary outcomes

Study Arms (2)

Autologous Chondrocyte Implantation

ACTIVE COMPARATOR

A diagnostic arthroscopy of the knee joint.The lesion is stabilized down to the subchondral bone, but not through it. Cartilage biopsy is taken from the medial femoral notch. The harvested cartilage is transported to the cell culture Laboratory and cultured for two weeks. The chondrocyte implantation: A mini-open arthrotomy is performed and the lesion is curetted down to subchondral bone, avoiding bleeding. The lesion is measured and a template of sterile aluminum foil is used to cut out a matching piece of collagen sheet which is used to contain the cells in the defect. The flap is sutured to the lesion and sealed with fibrin glue, leaving and opening at the upper part for injection of the cells. The last opening is then closed with a last stitch and fibrin glue.

Procedure: Autologous Chondrocyte Implantation

Arthroscopic Debridement

SHAM COMPARATOR

The AD group will be subjected to a diagnostic arthroscopy with a full inspection of the knee joint to ensure the inclusion criteria are fulfilled. Lose bodies are removed, any meniscal pathology is addressed. Inflamed synovium is debrided. The lesion is stabilized by debridement around the edges and down to the subchondral bone using a ring curette, but not through it. Microfracture or any other cartilage treatment will not be performed. No intra-articular local anesthetics will be used due to the possible harmful effect on cartilage \[41-43\]. All the operating surgeons will receive proper training in the operative procedure before study start.

Procedure: Arthroscopic Debridement

Interventions

Autologous Chondrocyte ImplantationPROCEDURE

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

Autologous Chondrocyte Implantation
Arthroscopic DebridementPROCEDURE

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

Arthroscopic Debridement

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Single symptomatic lesion of the trochlea, medial or lateral femoral condyle of the knee larger than 2 cm2.
  • Cartilage lesion ICRS grade 3 or 4.
  • More than 50 % of the menisci intact.
  • Ligamentous stable knee
  • Lysholm Score \< 75
  • Acceptable range of motion (5-105 degrees)

You may not qualify if:

  • Osteoarthritis
  • Malalignment \> 5 degrees measured on HKA (hip-knee-ankle) radiographs
  • Systemic arthritis
  • Previous cartilage surgery
  • Obesity BMI \> 30
  • Serious drig or alcohol abuse
  • Inability to answer questionnaires or partake in rehabilitation
  • Comorbidity that may influence surgery or rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Lørenskog, Oslo County, 0587, Norway

Location

Related Publications (3)

  • Randsborg PH, Brinchmann JE, Owesen C, Engebretsen L, Birkenes T, Hanvold HA, Benth JS, Aroen A. Autologous Chondrocyte Implantation Is Not Better Than Arthroscopic Debridement for the Treatment of Symptomatic Cartilage Lesions of the Knee: Two-Year Results From a Randomized-Controlled Trial. Arthrosc Sports Med Rehabil. 2024 Feb 16;6(2):100909. doi: 10.1016/j.asmr.2024.100909. eCollection 2024 Apr.

    PMID: 38495635RESULT

  • Banitalebi H, Owesen C, Aroen A, Tran HT, Myklebust TA, Randsborg PH. Is T2 mapping reliable in evaluation of native and repair cartilage tissue of the knee? J Exp Orthop. 2021 Apr 28;8(1):34. doi: 10.1186/s40634-021-00350-1.

    PMID: 33913035DERIVED

  • Randsborg PH, Brinchmann J, Loken S, Hanvold HA, Aae TF, Aroen A. Focal cartilage defects in the knee - a randomized controlled trial comparing autologous chondrocyte implantation with arthroscopic debridement. BMC Musculoskelet Disord. 2016 Mar 8;17:117. doi: 10.1186/s12891-016-0969-z.

    PMID: 26956476DERIVED

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Heidi Hanvold, PT

    Research coordinator

    PRINCIPAL INVESTIGATOR

  • asbjørn Årøen, MD, PhD

    Akerhus University hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 14, 2015

First Posted

December 22, 2015

Study Start

April 1, 2016

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

At publication.

Locations

NO(1)