Articular Chondral DefectNCT01747681
Results at 10 to 14 Years After Microfracture in the Knee
An observational study of Articular Chondral Defect, run by Bergen Orthopedic Study Group at 1 site in Norway.
Trial summary
Articular cartilage lesions are commonly occurring. In a prospective study of 1,000 knee arthroscopies focal chondral or osteochondral defects were found in 19% of the patients (Hjelle 2002). Chronic articular cartilage defects do not heal spontaneously. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Articular Chondral Defect
- What is being tested?
- Microfracture
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2012to Feb 2014
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients operated with a microfracture of articular chondral defects in the knee at the Deaconess University Hospital from 1999 to 2002.
Who may be able to join
- Patients with symptomatic focal full-thickness chondral lesions verified by arthroscopic examination and a minimum of 10-year follow-up.
Who cannot join
- Exclusion criteria were joint space narrowing (< 4 mm) on standard antero-posterior x-ray films,
- axial malpositioning,
- ligament instabilities or inability to follow the rehabilitation protocol.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Deaconess University Hospital, Haraldsplass
Bergen, Hordaland, 5009
About this study
Official title: Results at 10 to 14 Years After Microfracture in Articular Cartilage Defects in the Knee
Articular cartilage lesions are commonly occurring. In a prospective study of 1,000 knee arthroscopies focal chondral or osteochondral defects were found in 19% of the patients (Hjelle 2002). Chronic articular cartilage defects do not heal spontaneously. However, acute traumatic osteochondral lesions or surgically inflicted lesions extending into subchondral bone, e.g. by drilling (Pridie 1959), spongialization, abrasion or microfracture with an angled awl (Rodrigo 1994) causing the release of pluripotent mesenchymal stem cells from the bone marrow, may heal with repair tissue consisting of fibrous tissue, fibrocartilage or hyaline-like cartilage. The microfracture technique causes little damage to the subchondral bone plate and the risk of heat necroses caused by drilling or abrasion is eliminated. The quality of the repair tissue after these bone marrow stimulating techniques depends on various factors including the species and age of the individual, the size and localization of the defect, the surgical technique, e.g., how the subchondral bone plate is treated, and the postoperative rehabilitation protocol. Microfracture has been used in small traumatic defects in young sporting individuals (Steadman 2003) as well as in larger osteoarthritic lesions in older patients (Miller 2004, Steadman 2007). The purpose of the present study was to investigate the long-term clinical outcome 10 to 14 years after microfracture of articular cartilage defects in the knee and possible predictors of good and poor outcomes.
- Conditions
- Articular Chondral Defect
- Being tested
- Microfracture
- Keywords
- chondral defect, microfracture, arthroscopy, cartilage repair, outcome study, Lysholm score
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrofractureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Microfracture | Microfracture of articular chondral defect Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm knee score
All patients operated with a microfracture chondroplasty in the knee in 1999-2002 are invited to complete a patient-administered Lysholm score form
Measured: 10 to 14 years after surgery (in 2012-2013)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Articular Chondral DefectStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bergen Orthopedic Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eirik Eirik, MD, PhD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747681
- Sponsor's protocol ID
- 2012-Microfracture
- Status last verified
- Jan 2015
- First submitted
- 10 Dec 2012
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Solheim E, Hegna J, Inderhaug E, Oyen J, Harlem T, Strand T. Results at 10-14 years after microfracture treatment of articular cartilage defects in the knee. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1587-93. doi: 10.1007/s00167-014-3443-1. Epub 2014 Nov 23.
PubMed 25416965
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results at 10 to 14 Years After Microfracture in Articular Cartilage Defects in the Knee
- ClinicalTrials.gov ID
- NCT01747681
- Acronym / sponsor ID
- 2012-Microfracture
- Conditions
- Articular Chondral Defect
- Keywords
- chondral defect, microfracture, arthroscopy, cartilage repair, outcome study, Lysholm score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Bergen Orthopedic Study GroupUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Dec 2012 (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.
Articular cartilage lesions are commonly occurring. In a prospective study of 1,000 knee arthroscopies focal chondral or osteochondral defects were found in 19% of the patients (Hjelle 2002). Chronic articular cartilage defects do not heal spontaneously. However, acute traumatic osteochondral lesions or surgically inflicted lesions extending into subchondral bone, e.g. by drilling (Pridie 1959), spongialization, abrasion or microfracture with an angled awl (Rodrigo 1994) causing the release of pluripotent mesenchymal stem cells from the bone marrow, may heal with repair tissue consisting of fibrous tissue, fibrocartilage or hyaline-like cartilage. The microfracture technique causes little damage to the subchondral bone plate and the risk of heat necroses caused by drilling or abrasion is eliminated. The quality of the repair tissue after these bone marrow stimulating techniques depends on various factors including the species and age of the individual, the size and localization of the defect, the surgical technique, e.g., how the subchondral bone plate is treated, and the postoperative rehabilitation protocol. Microfracture has been used in small traumatic defects in young sporting individuals (Steadman 2003) as well as in larger osteoarthritic lesions in older patients (Miller 2004, Steadman 2007). The purpose of the present study was to investigate the long-term clinical outcome 10 to 14 years after microfracture of articular cartilage defects in the knee and possible predictors of good and poor outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microfracture | – | Procedure: MicrofractureMicrofracture of articular chondral defect |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients operated with a microfracture of articular chondral defects in the knee at the Deaconess University Hospital from 1999 to 2002.
Key inclusion criteria (1 listed)
- Patients with symptomatic focal full-thickness chondral lesions verified by arthroscopic examination and a minimum of 10-year follow-up.
Key exclusion criteria (3 listed)
- Exclusion criteria were joint space narrowing (< 4 mm) on standard antero-posterior x-ray films,
- axial malpositioning,
- ligament instabilities or inability to follow the rehabilitation protocol.
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 |
|---|---|---|
| Microfracture | Procedure or surgery | Microfracture |
Primary outcome
Lysholm knee score
Time frame: 10 to 14 years after surgery (in 2012-2013)
All patients operated with a microfracture chondroplasty in the knee in 1999-2002 are invited to complete a patient-administered Lysholm score form
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 27 Jan 2015.
- Results publication: PubMed 25416965Solheim E, Hegna J, Inderhaug E, Oyen J, Harlem T, Strand T. Results at 10-14 years after microfracture treatment of articular cartilage defects in the knee. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1587-93. doi: 10.1007/s00167-014-3443-1. Epub 2014 Nov 23.
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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.
Eirik Eirik, MD, PhD study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Articular Chondral Defect, run by Bergen Orthopedic Study Group 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 1 inclusion and 3 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 27 Jan 2015. 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. 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?
Lysholm knee score (time frame: 10 to 14 years after surgery (in 2012-2013)). 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 NCT01747681, which also lists 1 linked publication.
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 27 Jan 2015.