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…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in clinical outcome measured with International Knee Documentation
Committee questionnaire and information for cost-effectiveness analysis will be
assessed over 2 years.
Secondary outcome
difference in scores of KOOS, WOMET, work- and sports load, NRS, satisfaction,
and EQ5D. Histology of resected meniscal tissue.
Background summary
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.
Study 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.
Intervention
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.
Study burden and risks
The burden is primarily time (visit of outpatient clinic, and to fill in
questionnaires). There is no direct benefit from participation or group
relatedness.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
a history of trauma moment after which current complaints are initiated; age of 18-45 years; and presence of a meniscal tear grade 3 assessed on MRI.
Exclusion criteria
locking complaints knee; reparable meniscal tear (based on MRI); rupture of anterior or posterior cruciate ligament; knee OA; disabling co-morbidity; or insufficient command of Dutch or English language.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL46822.078.13 |