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Norwegian Cartilage Project - Microfracture

Primary Purpose

Knee Injury, Cartilage Injury

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Arthroscopic microfracture (MF)
Arthroscopic debridement (AD)
Sponsored by
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injury focused on measuring Articular cartilage, Focal cartilage injury, Focal cartilage injury in the knee, Knee cartilage, Microfracture, Debridement

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Akershus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Arthroscopic microfracture (MF)

Arthroscopic debridement (AD)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The Knee Injury and Osteoarthritis Outcome Score (KOOS) Other domains
The other four domains of the KOOS score (pain, symptoms, Activity of daily living, sport and recreational function) will act as secondary endpoints
Tegner Score
A validated knee-score to assess the level of physical Activity.
Lysholm Knee Score
A condition specific knee score that assesses 8 domains: limp, locking, swelling, pain, stair climbing, use of support, instability and squatting.
EQ5D
A generic measure of health status that produces a simple descriptive profile of Health status used in clinical evaluation of Health care.
Visual Analog Scale
A visual analogue scale for pain, where 0 represents no pain and 10 represents the worst pain imaginable.
Range of motion
Clinical evaluation of the joint range of motion
Magnetic Resonance Imaging (MRI) of the cartilage defect
A radiographic evaluation (MRI) of the cartilage injury at 2 years, to evaluate which patients have adequate cartilage quality 2 years after surgery. The MRI will be taken with a cartilage specific protocol.
A Hop test
Clinical evaluation of the knees agility, validated in knee sport medicine Research.

Full Information

First Posted
December 15, 2015
Last Updated
August 22, 2023
Sponsor
University Hospital, Akershus
Collaborators
Kristiansund Hospital, Alesund Hospital, Haukeland University Hospital, Diakonhjemmet Hospital, Oslo University Hospital, Haraldsplass Deaconess Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02637505
Brief Title
Norwegian Cartilage Project - Microfracture
Official Title
Focal Cartilage Defects in the Knee - A Randomized Controlled Trial Comparing Arthroscopic Microfracture With Arthroscopic Debridement
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 28, 2022 (Actual)
Study Completion Date
September 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
Kristiansund Hospital, Alesund Hospital, Haukeland University Hospital, Diakonhjemmet Hospital, Oslo University Hospital, Haraldsplass Deaconess Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
Focal cartilage defects in the knee - A randomized controlled trial comparing arthroscopic microfracture with arthroscopic debridement. Clinical compare the effect of arthroscopic microfracture (MF) with arthroscopic debridement (AD) in patients with symptomatic full thickness knee cartilage injuries less than 2cm2. Focal cartilage injuries in the knee might have devastating effect both in the short term and in the long term. Various surgical treatment options are available, with microfracture the most used technique globally. Meta-analysis and systematic reviews have required well-designed, long-term, multicenter studies to evaluate clinical outcomes of microfracture with the use of a "no treatment" group as a control group. H0: There is no difference in KOOS QoL after AM or AD 24 months after surgery. H1: There is a difference in KOOS QoL after AM or AD 24 months after surgery. Questionnaires: KOOS, Tegner score, Lysholm score, EQ-5D, VAS. Physical examination: range of motion and hop test. Radiology: x-ray and MRI of the knee. Primary aim: KOOS quality of life (QoL) subscore. Prospective, double-blinded parallel-group multicenter study with 2 treatment arms. Approx. 24 months inclusion and 24 months follow up. In total 4 years. All will be invited to participate in late controls after 5 and 10 years. 6 Norwegian hospitals: Akershus University Hospital, Oslo University Hospital - Ullevaal, Kristiansund Hospital, Aalesund Hospital, Diakonhjemmet Hospital and Haukeland University Hospital. 114 patients Inclusion: age 18-50 years old, single symptomatic cartilage defect on femoral condyle or trochlea. 2 treatment groups with 57 patients in each group. Follow up after 3 months (± 2 weeks), 6 months (± 4 weeks), 12 months (± 6 weeks) and 24 months (± 8 weeks). All will be invited to participate in late controls after 5 and 10 years. If any unforeseen complication outside normal clinical practice occurs, the sponsor representative will be contacted as soon as possible with a parallel message to the local coordinators at the involved hospitals. During each follow up, there will be a case report form (CRF) regarding complications and safety. A 5 mL venous blood sample will be drawn on the day of operation. The blood sample will be centrifuged before serum is pipetted in a sterile tube. The serum will be analyzed at Oslo University Hospital - Rikshospitalet on the cartilage biomarker microRNA-140 (miR-140). If normal distribution, aims will be analyzed using linear mixed models (LMM), and the primary aim will be performed as a post hoc test for the LMM, similar to performing a two-sample t-test. If no normal distribution, analysis will be performed using Mann-Whitney U-test. Detecting a difference of 10 with 80 percent Power, uing a standard deviation of 18, this yields 52 patients in each group. By adding 10% due to loss during follow-up, we therefore plan to include a total of 114 patients. No interim analysis will be done. Monitor from Health Møre and Romsdal HF. The end of this study is 24 months after the last included patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injury, Cartilage Injury
Keywords
Articular cartilage, Focal cartilage injury, Focal cartilage injury in the knee, Knee cartilage, Microfracture, Debridement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arthroscopic microfracture (MF)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arthroscopic debridement (AD)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic microfracture (MF)
Intervention Description
Arthroscopy With microfracture procedure
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic debridement (AD)
Intervention Description
Arthroscopy With debridement procedure
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life
Description
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.
Time Frame
24 months follow up
Secondary Outcome Measure Information:
Title
The Knee Injury and Osteoarthritis Outcome Score (KOOS) Other domains
Description
The other four domains of the KOOS score (pain, symptoms, Activity of daily living, sport and recreational function) will act as secondary endpoints
Time Frame
24 months follow up
Title
Tegner Score
Description
A validated knee-score to assess the level of physical Activity.
Time Frame
24 months follow up
Title
Lysholm Knee Score
Description
A condition specific knee score that assesses 8 domains: limp, locking, swelling, pain, stair climbing, use of support, instability and squatting.
Time Frame
24 months follow up
Title
EQ5D
Description
A generic measure of health status that produces a simple descriptive profile of Health status used in clinical evaluation of Health care.
Time Frame
24 months follow up
Title
Visual Analog Scale
Description
A visual analogue scale for pain, where 0 represents no pain and 10 represents the worst pain imaginable.
Time Frame
24 months follow up
Title
Range of motion
Description
Clinical evaluation of the joint range of motion
Time Frame
24 months follow up
Title
Magnetic Resonance Imaging (MRI) of the cartilage defect
Description
A radiographic evaluation (MRI) of the cartilage injury at 2 years, to evaluate which patients have adequate cartilage quality 2 years after surgery. The MRI will be taken with a cartilage specific protocol.
Time Frame
24 months follow up
Title
A Hop test
Description
Clinical evaluation of the knees agility, validated in knee sport medicine Research.
Time Frame
24 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tommy F Aae, MD,PhD
Organizational Affiliation
National coordinator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Øystein Lian, MD
Organizational Affiliation
Kristian sund sykehus
Official's Role
Study Director
Facility Information:
Facility Name
Akershus University Hospital
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33913035
Citation
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.
Results Reference
derived
PubMed Identifier
27422025
Citation
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.
Results Reference
derived

Learn more about this trial

Norwegian Cartilage Project - Microfracture

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