TerminatedPhase 4

Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy

Stopped: The correlation coefficient at the interim analysis with results for all three groups pooled, did not reach the level of statistical significance of (p\<0.05).

United States165 participantsStarted 2008-04

Plain-language summary

The aim of this study is to describe changes at the site of the study patient's articular cartilage lesion on the femoral condyle with multiple magnetic resonance imaging (MRI) outcomes 6 months after treatment using one of three standard surgical treatment methods: 1) lavage debridement; 2) mechanical debridement; 3) mechanical and radiofrequency-based debridement.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:Screening * Age between 18 and 60 years * BMI \<35 * Meniscal tear (medial or lateral) diagnosed by H+P exam and/or imaging in the index knee * No severe joint space narrowing (IKDC Classification) seen on weight-bearing AP X-ray in the index knee * No avascular necrosis in the index knee as evidenced by preop MRI obtained within 6 months prior to randomization * No Varus (\>10 degrees) or Valgus (\>15 degrees)knee deformities as seen by AP X-ray in the index knee * Minimal or no abnormality of contralateral knee as shown by clinical exam and/or imaging * Candidate for unilateral arthroscopic treatment of the knee * Visual Analog Scale (VAS) pain score of 30 mm or greater in the index knee at the time of screening * Must be able to undergo MRI at required time points per appendix D * Physically and mentally willing and able to comply with study requirements * Must be willing and able to follow the standardized rehabilitation protocol (Appendix C) * Subject must sign IRB approved informed consent form Arthroscopy Inclusion Criteria: * Arthroscopic confirmation of ICRS Grade II or III chondral lesion on the medial or lateral femoral condyle Exclusion Criteria: Screening * Knee instability, malalignment, or patellar tracking dysfunction in the index knee * Inflammatory rheumatoid arthritis or other systemic inflammatory arthritis in the index knee or contralateral knee * Previous total meniscectomy in the index knee * Previous surgical treatment of the in…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion

Timeframe: 6 months after arthroscopy

Trial details

NCT IDNCT00613535

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-06

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