Knee InjuryNCT02637505
Norwegian Cartilage Project - Microfracture
A study testing Arthroscopic microfracture (MF) and Arthroscopic debridement (AD) in people with Knee Injury and Cartilage Injury, run by University Hospital, Akershus at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Knee Injury, Cartilage Injury
- What is being tested?
- Arthroscopic microfracture (MF) and Arthroscopic debridement (AD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2016to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Inability to answer questionnaires or partake in rehabilitation
- Comorbidity that may influence surgery or rehabilitation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Focal Cartilage Defects in the Knee - A Randomized Controlled Trial Comparing Arthroscopic Microfracture With Arthroscopic Debridement
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).
Read the 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.
- Conditions
- Knee Injury, Cartilage Injury
- Being tested
- Arthroscopic microfracture (MF), Arthroscopic debridement (AD)
- Keywords
- Articular cartilage, Focal cartilage injury, Focal cartilage injury in the knee, Knee cartilage, Microfracture, Debridement
- Medical subject headings
- Knee Injuries, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic microfracture (MF)Procedure or surgery
Arthroscopy With microfracture procedure
Arthroscopic debridement (AD)Procedure or surgery
Arthroscopy With debridement procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Arthroscopic debridement (AD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months follow up
Secondary outcomes (8)
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
Measured: 24 months follow up
Tegner Score
A validated knee-score to assess the level of physical Activity.
Measured: 24 months follow up
Lysholm Knee Score
A condition specific knee score that assesses 8 domains: limp, locking, swelling, pain, stair climbing, use of support, instability and squatting.
Measured: 24 months follow up
EQ5D
A generic measure of health status that produces a simple descriptive profile of Health status used in clinical evaluation of Health care.
Measured: 24 months follow up
Visual Analog Scale
A visual analogue scale for pain, where 0 represents no pain and 10 represents the worst pain imaginable.
Measured: 24 months follow up
Range of motion
Clinical evaluation of the joint range of motion
Measured: 24 months follow up
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.
Measured: 24 months follow up
A Hop test
Clinical evaluation of the knees agility, validated in knee sport medicine Research.
Measured: 24 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Kristiansund Hospital, Alesund Hospital, Haukeland University Hospital, Diakonhjemmet Hospital, Oslo University Hospital, Haraldsplass Deaconess Hospital
- Responsible party
- Principal investigator, Asbjorn Aroen, University Hospital, Akershus
- Investigators
- Tommy F Aae, MD,PhD, Principal investigator, National coordinatorØystein Lian, MD, Study director, Kristian sund sykehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637505
- Sponsor's protocol ID
- 2015/2202
- Status last verified
- Jan 2025
- First submitted
- 15 Dec 2015
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33913035Aae 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.
PubMed 27422025
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Cartilage Defects in the Knee - A Randomized Controlled Trial Comparing Arthroscopic Microfracture With Arthroscopic Debridement
- ClinicalTrials.gov ID
- NCT02637505
- Acronym / sponsor ID
- 2015/2202
- Conditions
- Knee Injury, Cartilage Injury
- Keywords
- Articular cartilage, Focal cartilage injury, Focal cartilage injury in the knee, Knee cartilage, Microfracture, Debridement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Kristiansund Hospital, Alesund Hospital, Haukeland University Hospital, Diakonhjemmet Hospital, Oslo University Hospital, Haraldsplass Deaconess Hospital
- Study start
- Jan 2016
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic microfracture (MF) | Active comparator | Procedure: Arthroscopic microfracture (MF)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. |
| Arthroscopic debridement (AD) | Sham comparator | Procedure: Arthroscopic debridement (AD)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Osteoarthritis
- Malalignment > 5 degrees measured clinically, and if uncertainty on HKA radiographs
- Systemic arthritis
- Previous cartilage surgery except OCD fixation
- Obesity BMI > 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic microfracture (MF)Arthroscopy With microfracture procedure | Procedure or surgery | Arthroscopic microfracture (MF) |
| Arthroscopic debridement (AD)Arthroscopy With debridement procedure | Procedure or surgery | Arthroscopic debridement (AD) |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life
Time frame: 24 months follow up
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.
8 secondary outcomes
The Knee Injury and Osteoarthritis Outcome Score (KOOS) Other domains
Time frame: 24 months follow up
Tegner Score
Time frame: 24 months follow up
Lysholm Knee Score
Time frame: 24 months follow up
EQ5D
Time frame: 24 months follow up
Visual Analog Scale
Time frame: 24 months follow up
Range of motion
Time frame: 24 months follow up
Magnetic Resonance Imaging (MRI) of the cartilage defect
Time frame: 24 months follow up
A Hop test
Time frame: 24 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Derived from this study: PubMed 33913035Banitalebi 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.
- Derived from this study: PubMed 27422025Aae 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tommy F Aae, MD,PhD principal investigator
National coordinator
Øystein Lian, MD study director
Kristian sund sykehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic microfracture (MF) and Arthroscopic debridement (AD) in people with Knee Injury and Cartilage Injury, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (time frame: 24 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637505, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.