Lesion of Joint Capsule of Knee RegionNCT01421290
Treatment of Cartilage Lesions in Flanders Today
A study testing Surgery and Conservative comparator in people with Lesion of Joint Capsule of Knee Region, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The hypothesis of this study is to investigate whether surgical intervention is necessary for patients who suffer from cartilage lesions of the knee, or whether this surgical intervention can be avoided or postponed by using conservative treatment options such as physiotherapy, nutrition supplements, intra-articular… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Lesion of Joint Capsule of Knee Region
- What is being tested?
- Surgery and Conservative comparator
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Dec 2015
- 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
- Symptomatic single cartilage lesions of the femur condyles
- Size of the lesion, determined by MRI:
- between 1-2 cm² for the group who will receive conservative treatment between 2-5 cm² for the group who will have surgery
- Mechanical joint pain, assessed by a 100 mm Visual Analogue Scale: > 40 mm for the conservative group, > 60 mm for the operative group
- Agree to stop using analgetics and NSAID's 2 weeks before the First respond of the surveys, and 2 weeks before the second respond of the surveys. Only paracetamol (4g/day) is allowed.
- men and women, women have to use contraceptive to avoid pregnancies.
- age between 18 - 50 years
Who cannot join
- participation in concurrent trials
- participation in previous trials within 3 months
- subjects with HIV, hepatitis, syphilis
- malignancy
- alcohol and drug abuse
- poor general health condition as judged by the investigator
Show all 26Show fewer
- osteochondritis dissecans
- advanced osteoarthritis (kellgren 2-4)
- known allergy to penicillins and gentamicin or presence of multiple severe allergies
- complex ligamentous instability of the knee
- lateral meniscus lesion or more than 50% resection of medial meniscus
- Varus or valgus misalignment exceeding 3° (kissing lesions out)
- Mosaicplasty (OATS)
- Microfracture performed less than 1 year before baseline
- Received hyaluronic acid intra-articular injections into the afflicted knee within the last six months of baseline
- Taking specific OA drugs, such as chondroitin sulphate, diacerein, capsaicin within two weeks of the baseline visit
- Corticosteroid therapy by systemic or intra-articular route within the last month of baseline or intramuscular or oral corticosteroids within the last two weeks of baseline
- Chronic use of anticoagulants
- Uncontrolled diabetes
- Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted knee
- Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
- Any evidence of the following disease in the target joint: septic arthritis, inflammatory joint disease, hematochrosis, collagen gene mutations
- Current diagnosis of osteomyelitis
- A blood result showing liver enzymes more than two times the upper limit of normal or any other result that in the clinical investigator's mind is important clinically
- CRP level greater than 10g/l
- Unwilling to participate in post-operative rehabilitation protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome After Treating Cartilage Defects in the Knee by Surgical or Conservative Means
The hypothesis of this study is to investigate whether surgical intervention is necessary for patients who suffer from cartilage lesions of the knee, or whether this surgical intervention can be avoided or postponed by using conservative treatment options such as physiotherapy, nutrition supplements, intra-articular injections, bracing.
Forty patients suffering from cartilage lesions in their knee joint will be selected preoperatively. All these patients fulfil certain inclusion- and exclusion criteria. They will be asked to respond to 3 different questionnaires. These questionnaires include the visual analogue scale to evaluate pain (VAS), the Knee injury and Osteoarthritis Outcome Score or KOOS and the International Knee Documentation Committee (IKDC) form to evaluate the effect of their cartilage lesion on activities in daily life. Six months later +/- 20 patients will have had surgery and +/- 20 patients will have had conservative treatment, both groups of patients will be asked to respond again to the 3 different questionnaires. The outcome of the results will tell us more of the evolution both between groups and in each group separately.
- Conditions
- Lesion of Joint Capsule of Knee Region
- Being tested
- Surgery, Conservative comparator
- Keywords
- Cartilage lesions in the knee joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Knee surgery
Conservative comparatorOther
Kinesitherapy, intra-articular injection, wearing a brace, thermotherapy, intake of supplements.
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Active comparator | Not described Receives: Other: Conservative comparator |
| Surgery | Active comparator | Not described Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaires to decide which intervention will be performed.
The questionnaires include the visual analogue scale to evaluate pain (VAS), the Knee injury and Osteoarthritis Outcome Score or KOOS and the International Knee Documentation Committee subjective knee form (IKDC) to evaluate the effect of their cartilage lesion on activities in daily life
Measured: At day 1
Secondary outcomes (1)
Questionnaires to measure patient satisfaction.
The questionnaires include the visual analogue scale to evaluate pain (VAS), the Knee injury and Osteoarthritis Outcome Score or KOOS and the International Knee Documentation Committee subjective knee form (IKDC) to evaluate the effect of their cartilage lesion on activities in daily life.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lesion of Joint Capsule of Knee RegionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421290
- Sponsor's protocol ID
- 2011/399
- Status last verified
- Dec 2022
- First submitted
- 17 Aug 2011
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome After Treating Cartilage Defects in the Knee by Surgical or Conservative Means
- ClinicalTrials.gov ID
- NCT01421290
- Acronym / sponsor ID
- 2011/399
- Conditions
- Lesion of Joint Capsule of Knee Region
- Keywords
- Cartilage lesions in the knee joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Aug 2011 (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.
The hypothesis of this study is to investigate whether surgical intervention is necessary for patients who suffer from cartilage lesions of the knee, or whether this surgical intervention can be avoided or postponed by using conservative treatment options such as physiotherapy, nutrition supplements, intra-articular injections, bracing.
Forty patients suffering from cartilage lesions in their knee joint will be selected preoperatively. All these patients fulfil certain inclusion- and exclusion criteria. They will be asked to respond to 3 different questionnaires. These questionnaires include the visual analogue scale to evaluate pain (VAS), the Knee injury and Osteoarthritis Outcome Score or KOOS and the International Knee Documentation Committee (IKDC) form to evaluate the effect of their cartilage lesion on activities in daily life. Six months later +/- 20 patients will have had surgery and +/- 20 patients will have had conservative treatment, both groups of patients will be asked to respond again to the 3 different questionnaires. The outcome of the results will tell us more of the evolution both between groups and in each group separately.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Active comparator | Other: Conservative comparator |
| Surgery | Active comparator | Procedure: Surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Symptomatic single cartilage lesions of the femur condyles
- Size of the lesion, determined by MRI:
- between 1-2 cm² for the group who will receive conservative treatment between 2-5 cm² for the group who will have surgery
- Mechanical joint pain, assessed by a 100 mm Visual Analogue Scale: > 40 mm for the conservative group, > 60 mm for the operative group
- Agree to stop using analgetics and NSAID's 2 weeks before the First respond of the surveys, and 2 weeks before the second respond of the surveys. Only paracetamol (4g/day) is allowed.
Key exclusion criteria (26 listed)
- participation in concurrent trials
- participation in previous trials within 3 months
- subjects with HIV, hepatitis, syphilis
- malignancy
- alcohol and drug abuse
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 |
|---|---|---|
| SurgeryKnee surgery | Procedure or surgery | Surgery |
| Conservative comparatorKinesitherapy, intra-articular injection, wearing a brace, thermotherapy, intake of supplements. | Other | Conservative treatment |
Primary outcome
Questionnaires to decide which intervention will be performed.
Time frame: At day 1
The questionnaires include the visual analogue scale to evaluate pain (VAS), the Knee injury and Osteoarthritis Outcome Score or KOOS and the International Knee Documentation Committee subjective knee form (IKDC) to evaluate the effect of their cartilage lesion on activities in daily life
1 secondary outcome
Questionnaires to measure patient satisfaction.
Time frame: At 6 months
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 15 Dec 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and Conservative comparator in people with Lesion of Joint Capsule of Knee Region, run by University Hospital, Ghent at 1 site in Belgium.
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 7 inclusion and 26 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 15 Dec 2022. 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 Belgium. 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?
Questionnaires to decide which intervention will be performed. (time frame: At day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2022.