Norwegian Cartilage Project - Microfracture

NCT02637505 | Completed DMC

• 1 other identifier: 2015/2202
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

114 patients between 18 and 50 years with an isolated focal cartilage defect in the knee will be randomized to either receive arthroscopic microfracture 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 as well as clinical examination and radiological findings at 2 years (MRI).

Conditions

Knee Injury; Cartilage Injury

Keywords

Articular cartilage; Focal cartilage injury; Focal cartilage injury in the knee; Knee cartilage; Microfracture; Debridement

Outcome Measures

Primary Outcomes (1)

• 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. The primary aim is where the primary aim is the difference in KOOS QoL subscore in the AM group compared to the AD group at 24 months follow up. It is not planned any interim analysis before 24 months follow up.

  24 months follow up

Secondary Outcomes (8)

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

  24 months follow up

• Tegner Score

  24 months follow up

• Lysholm Knee Score

  24 months follow up

• EQ5D

  24 months follow up

• Visual Analog Scale

  24 months follow up

Study Arms (2)

Arthroscopic microfracture (MF)

ACTIVE COMPARATOR

The AM group will be subjected to a diagnostic arthroscopy with a full inspection of the knee joint to ensure the inclusion criteria are fulfilled. The cartilage is cut sharp forming a rim of 90 degrees. The calcified layer is removed using a curette before an arthroscopic awl is then used to perform multiple holes ("microfractures") from the periphery towards the center. The microfractures are 3 - 4 mm apart and 2 - 4 mm deep into the subchondral bone. The correct and successful technique is confirmed by direct visualization: while reducing the fluid pump pressure, the release of marrow fat droplets and blood will be observed.

Procedure: Arthroscopic microfracture (MF)

Arthroscopic debridement (AD)

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. The lesion is stabilized, debriding all loose or marginally attached cartilage from the surrounding rim to form a stable edge of healthy cartilage around the defect using a ring curette, where cartilage slops down to the defect.

Procedure: Arthroscopic debridement (AD)

Interventions

Arthroscopic microfracture (MF) PROCEDURE

Arthroscopy With microfracture procedure

Arthroscopic microfracture (MF)

Arthroscopic debridement (AD) PROCEDURE

Arthroscopy With debridement procedure

Arthroscopic debridement (AD)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Single symptomatic lesion of the trochlea, medial or lateral femoral condyle of the knee less 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 clinically, and if uncertainty on HKA radiographs
• Systemic arthritis
• Previous cartilage surgery except OCD fixation
• Obesity BMI \> 30
• Serious drig or alcohol abuse
• Inability to answer questionnaires or partake in rehabilitation
• Comorbidity that may influence surgery or rehabilitation
• Pregnancy

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Kristiansund Hospital: collaborator
• Alesund Hospital: collaborator
• Haukeland University Hospital: collaborator
• Diakonhjemmet Hospital: collaborator
• Oslo University Hospital: collaborator
• Haraldsplass Deaconess Hospital: collaborator

Study Sites (1)

Akershus University Hospital

Lørenskog, 1478, Norway

Location

Related Publications (2)

• 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: 33913035 DERIVED

• Aae TF, Randsborg PH, Breen AB, Visnes H, Vindfeld S, Sivertsen EA, Loken S, Brinchmann J, Hanvold HA, Aroen A. Norwegican Cartilage Project - a study protocol for a double-blinded randomized controlled trial comparing arthroscopic microfracture with arthroscopic debridement in focal cartilage defects in the knee. BMC Musculoskelet Disord. 2016 Jul 16;17:292. doi: 10.1186/s12891-016-1156-y.

  PMID: 27422025 DERIVED

MeSH Terms

Conditions

Knee Injuries; Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Tommy F Aae, MD,PhD

  National coordinator

  PRINCIPAL INVESTIGATOR

• Øystein Lian, MD

  Kristian sund sykehus

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 22, 2015
• Study Start: January 1, 2016
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)