The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients (SLAMSHAM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Slagelse Hospital
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Kristoffer Hare, Slagelse Hospital
ClinicalTrials.gov Identifier:
NCT01264991
First received: December 21, 2010
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

BACKGROUND Osteoarthritis (OA) is the most common form of arthritis and the knee is one of the most affected joints. The meniscus plays an important role in the development of knee OA. It is unclear whether a degenerative meniscus tear is a risk factor in developing knee OA or a sign of the disease. The standard treatment for a degenerative meniscus tear is an arthroscopic partial meniscectomy (APM). There is strong evidence that this puts the knee at high risk of later developing OA. Earlier studies have shown a significant placebo effect from surgical procedures, in general, and an arthroscopic knee procedure, in particular.

PURPOSE The overall purpose of this study is to gather information that might lead to a reduction in the development of OA in middle-aged patients. The investigators hypothesise that the benefit from an arthroscopic partial meniscectomy is due to the placebo effect measured on self-reported outcomes, and that the meniscectomy contributes to the development of knee OA as seen on radiography.

METHODS The investigators will include 100 patients aged from 35 to 55 years with an MRI-confirmed medial meniscus tear and without knee OA (excluding patients with Grade 3 or 4 knee OA on the Kellgren-Lawrence classification). Participants will be randomised to either a standard APM procedure or a sham procedure and both groups will receive standard post-operative care. The primary outcomes will be a self-reported questionnaire, the KOOS score, and a functionality test after 3 and 24 months.


Condition Intervention
Degenerative Meniscus Tear
Procedure: Arthroscopic partial meniscectomy
Procedure: Sham procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients - A Double-Blinded Randomized Placebo (Sham) Controlled Multi-Centre Trial

Resource links provided by NLM:


Further study details as provided by Slagelse Hospital:

Primary Outcome Measures:
  • Knee injury and Osteoarthritis Outcome Score - KOOS [ Time Frame: 2 year follow-up ] [ Designated as safety issue: No ]

    The primary outcome at 2 years follow-up will be a self-reported questionnaire, the Knee injury and Osteoarthritis Outcome Score (KOOS), comprising five different subscales:

    1. pain
    2. other symptoms
    3. activities in daily living (ADL)
    4. function in sport and recreation
    5. knee-related quality of life (QOL) A mean of the 5 subscales will be calculated (KOOS5 = [KOOSpain + KOOSsymptoms + KOOSADL + KOOSsport&rec KOOSQOL] / 5. Range 0 to 100, worst to best)


Secondary Outcome Measures:
  • One-leg jump test [ Time Frame: 2 year follow-up ] [ Designated as safety issue: No ]
    Subjects will perform 2 practice trials and then two test trials on each leg. The best of the two test trials will be used. Symmetry indices will be calculated for the one-leg hop test as (injured side/uninjured side) x 100

  • Knee-bending test [ Time Frame: 2 year follow-up ] [ Designated as safety issue: No ]
    A maximum number of knee-bends performed in 30 seconds as a test for physical function. This test has been used on similar patient groups in other studies and has been found to be a reliable test

  • Knee extension strength [ Time Frame: 2 year follow-up ] [ Designated as safety issue: No ]
    A handheld dynamometer (Powertrack Commander) will be used to evaluate the quadriceps muscle performance by measuring the knee-extension strength. Isometric muscle testing is commonly used in the literature and the reliability for the isometric muscle tests with a hand held dynamometer have previously been reported to be satisfactory.

  • EQ-5D [ Time Frame: 2 year follow-up ] [ Designated as safety issue: No ]
    The EQ-5D health score will be evaluated at baseline and at 3 and 24 months as a generic measure of health for clinical and economic appraisal. EQ-5D consists of two pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, severe problems.

  • SF-36 [ Time Frame: 2 year follow-up ] [ Designated as safety issue: No ]
    The SF-36 Health Survey - Acute (1 week re-call) will be used as a generic measure of patient health status and in differentiating the health benefits produced by the different treatments. This will also be evaluated at baseline and at 3 and 24 months. The SF-36 Is compromised of an 8-scale profile of functional health and well-being scores comparing the relative burden of diseases.

  • Development of knee osteoarthritis [ Time Frame: 5 year follow-up ] [ Designated as safety issue: No ]
    A fixed-flexion radiography procedure, with use of SynaFlex, will be implemented to investigate the development of OA on a long-term basis . Incident marginal tibiofemoral osteophyte will be the outcome at a 5-year follow-up


Estimated Enrollment: 150
Study Start Date: December 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APM group Procedure: Arthroscopic partial meniscectomy
The arthroscopic partial meniscectomy will be performed on an outpatient basis by experienced surgeons at a level of at least attending physicians or at the last year of residency. All arthroscopies will be performed in general anaesthesia combined with local anaesthesia. After general anaesthesia is induced, the knee will be examined for stability. Thereafter two standard portals on the lateral and medial side of the ligamentum patella will be created but no outflow cannula inserted. An arthroscope will be used with a pressure-controlled irrigation system. Tourniquet use will be according to surgeon preference. The strategy for the meniscectomy will be to preserve as much tissue as possible. A standard operation protocol will be used to document possible findings in cartilage, ligaments, synovium and the medial and lateral meniscus. Meniscus lesions and type of will be registered and changes in the articular cartilage will be classified according to the ICRS classification
Placebo Comparator: Sham group Procedure: Sham procedure
The placebo procedure will be performed under the same conditions as above. The patient will be fully sedated in general anaesthesia. As above, the stability of the knee will be examined. Local anaesthetic will be applied as above and 2 skin incisions will be made at the same location and the same size as above. Then the knee will be manipulated as if a real arthroscopy were being done, the spillage of water and all the other equipment needed for an arthroscopy will be used and manipulated. No instruments will enter the portals for arthroscopy to avoid the possibility of osteochondral lesions and unwanted interventions by the surgeon.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with knee pain for more than 2 months without significant trauma (only the index knee will be included)
  2. MRI-confirmed medial meniscus lesion (patients with a medial meniscus lesion AND a lateral lesion will also be included)
  3. Age 35-55 years*
  4. Eligible for outpatient surgery - ASA score 1-2

Exclusion Criteria:

  1. Patients in need of acute surgery e.g. locking knees, high-energy trauma
  2. Symptoms associated with other musculoskeletal co-morbidities overriding the symptoms of the knee
  3. Grade 3 or 4 knee OA on the Kellgren-Lawrence classification
  4. Knee surgery within the last 2 years
  5. Obese patients with BMI > 35
  6. Patients with ischemic heart disease
  7. Patients with diabetic late-complications
  8. Patients with thrombophilia
  9. Pregnancy
  10. Patients unable to speak Danish
  11. Patients with drug or alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264991

Contacts
Contact: Kristoffer B Hare, MD 58559011 ext +45 kbhr@regionsjaelland.dk

Locations
Denmark
Næstved Hospital Not yet recruiting
Næstved, Region Zealand, Denmark, 4800
Contact: Jens-Erik Varmarken, MD    56512000 ext +45    jva@regionsjaelland.dk   
Principal Investigator: Kristoffer B Hare, MD         
Slagelse Hospital Recruiting
Slagelse, Region Zealand, Denmark, 4200
Contact: Peter M Bernt, MD    58559000 ext +45    pmbe@regionsjaelland.dk   
Principal Investigator: Kristoffer B Hare, MD         
Sponsors and Collaborators
Slagelse Hospital
University of Southern Denmark
Investigators
Study Chair: Ewa Roos, Professor Research Unit of Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense
Principal Investigator: Kristoffer B Hare, MD Dept. of Orthopadeics, Slagelse Hospital, Region Zealand
  More Information

No publications provided by Slagelse Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristoffer Hare, MD, Slagelse Hospital
ClinicalTrials.gov Identifier: NCT01264991     History of Changes
Other Study ID Numbers: SJ-183
Study First Received: December 21, 2010
Last Updated: March 4, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Slagelse Hospital:
Sham
Meniscus tear
Meniscectomy

ClinicalTrials.gov processed this record on August 19, 2014