No registrations found.
ID
Source
Brief title
Health condition
-traumatic meniscal tear
-meniscectomy
-physical therapy
-cost-effectiveness
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical relevant difference in International Knee Documentation Committee (IKDC) questionnaire
Secondary outcome
Difference 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
Background summary
Rationale: 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.
Study objective
An arthroscopic partial meniscectomy is a cost-effective intervention to treat patients with clinical complaints of the knee because of a traumatic meniscal tear.
Study design
3, 6, 9, 12 and 24 months
Intervention
Physical therapy
Arthroscopic partial meniscectomy
M. Reijman
Wytemaweg 80, 3015 CN Rotterdam, kamer HS-104
Rotterdam
The Netherlands
010 7033642
m.reijman@erasmusmc.nl
M. Reijman
Wytemaweg 80, 3015 CN Rotterdam, kamer HS-104
Rotterdam
The Netherlands
010 7033642
m.reijman@erasmusmc.nl
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4380 |
NTR-old | NTR4511 |
CCMO | NL46822.078.13 |
OMON | NL-OMON41304 |