Treatment of Cartilage Lesions in Flanders Today

NCT01421290 | Completed

• 1 other identifier: 2011/399
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Cartilage lesions in the knee joint

Outcome Measures

Primary Outcomes (1)

• 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

  At day 1

Secondary Outcomes (1)

• Questionnaires to measure patient satisfaction.

  At 6 months

Study Arms (2)

Conservative treatment

ACTIVE COMPARATOR

Other: Conservative comparator

Surgery

ACTIVE COMPARATOR

Procedure: Surgery

Interventions

Surgery PROCEDURE

Knee surgery

Surgery

Conservative comparator OTHER

Kinesitherapy, intra-articular injection, wearing a brace, thermotherapy, intake of supplements.

Conservative treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital, Ghent

Ghent, Belgium

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 22, 2011
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

BE (1)