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A Study of Traumatic meniscal tears: Arthroscopic Resection vs Rehabilitation


- candidate number17454
- NTR NumberNTR4511
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-apr-2014
- Secondary IDsNL46822.078.13 CCMO
- Public TitleA Study of Traumatic meniscal tears: Arthroscopic Resection vs Rehabilitation
- Scientific TitleA Study of Traumatic meniscal tears: Arthroscopic Resection vs Rehabilitation
- ACRONYMSTARR-trial
- hypothesisAn arthroscopic partial meniscectomy is a cost-effective intervention to treat patients with clinical complaints of the knee because of a traumatic meniscal tear.
- Healt Condition(s) or Problem(s) studiedTibial meniscus, Physiotherapy, Cost-effectiveness
- Inclusion criteria-Age of 18-45 years
-Presence of a meniscal tear grade 3 assessed on MRI
-History of trauma
- Exclusion criteria-Locking complaints of the knee
-Reparable meniscal tear (based on MRI)
-Rupture of anterior or posterior cruciate ligament
-Knee osteoarthritis
-Disabling co-morbidity
-Insufficient command of Dutch or English language
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate31-mrt-2018
- Target number of participants154
- InterventionsPhysical therapy
Arthroscopic partial meniscectomy
- Primary outcomeClinical relevant difference in International Knee Documentation Committee (IKDC) questionnaire
- Secondary outcomeDifference in:
- Knee injury and Osteoarthritis Outcome Score (KOOS)
- Western Ontario Meniscal Evaluation Tool (WOMET)
- Number Rating Scale for knee pain (NRS)
- Work- and sportsload
- Satisfaction
- EQ5D
- Pain medication
- Side effects
- Timepoints3, 6, 9, 12 and 24 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES S. Eijgenraam
- CONTACT for SCIENTIFIC QUERIES S. Eijgenraam
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications-
- Brief summaryRationale: Arthroscopic partial meniscectomy is the most popular intervention under orthopaedic surgeons to treat patients with meniscal tears. However, cost-effectiveness of this procedure is seriously questioned. Especially, in case of a traumatic meniscal tear without locking complaints evidence is lacking whether an arthroscopic intervention is the most optimal treatment.
Objective: To evaluate the cost-effectiveness of arthroscopic partial meniscectomy compared to non-operative treatment strategy. The hypothesis is that an arthroscopic partial meniscectomy is a cost-effective intervention to treat patients with clinical complaints of the knee because of a traumatic meniscal tear (superiority study).
Study design: Open-labeled randomized clinical trial.
Study population: Patients are eligible in the age of 18-45 years consulting an orthopedic surgeon with a history of trauma moment after which current signs and symptoms of a meniscal tear are initiated.
Intervention (if applicable): Patients will be randomized in a) arthroscopic partial meniscectomy; or in b) non-operative treatment strategy. In group a): arthroscopic treatment will be performed, followed by an exercise program if indicated according to Dutch guidelines of physical therapists and orthopedic surgeons. In group b): according to the Dutch guideline for General Practitioners advice, exercise therapy (standardized program), and pain medication will be provided.
Main study parameters/endpoints: Difference in clinical outcome measured with International Knee Documentation Committee questionnaire and information for costeffectiveness analysis will be assessed over 2 years.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden is primarily time (visit of outpatient clinic, and to fill in questionnaires). There is no direct benefit from participation or group relatedness.
Arthroscopic meniscectomy and non-surgical treatment are both options in the standard care of active patients, with complaints of a traumatic meniscal tear.
- Main changes (audit trail)
- RECORD14-apr-2014 - 13-mei-2014


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