N/A
N=27
Muscle Weakness and Post-traumatic Knee OA
Meniscectomy
Bottom Line
View on ClinicalTrials.gov: NCT01879852 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score — 22.2; 20.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Quadriceps intensive strengthening (Behavioral); Standard rehabilitation (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score |
22.2; 20.6 | — |
| PRIMARY Change in Tibial Articular Cartilage Volume |
0.18; -1.24 | — |
| SECONDARY Single Leg Forward Hop Index |
87.1; 90.1 | — |
| SECONDARY Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II) |
0.01; -0.11 | — |
Summary
This is a single-center, randomized, single-blind (evaluator) study. Enrolled patients had a traumatic meniscal tear and underwent meniscectomy. The study included 6 weeks (12 visits) of standard or quadriceps intensive rehabilitation. The objective of the study was to determine the effect of quadriceps intensive rehabilitation on knee function and articular cartilage.
Eligibility Criteria
Inclusion Criteria
- traumatic onset meniscal tear (i.e. specific mechanism of injury)
- meniscectomy surgery performed within 12 months of index injury
- meniscal tear confirmed at the time of surgery
- subject anticipates living in close proximity to Gainesville for one year following surgery.
Exclusion Criteria
- bilateral injury
- concomitant ligamentous injury
- previous knee injury
- articular cartilage defect > Grade II on Outerbridge scale
- patellofemoral joint pain > 3/10 with activity
- lower limb alignment > 5 degrees of valgus or varus
- contraindication to an MR examination including: a pacemaker, metal implants which are not MR compatible, pregnancy and severe claustrophobia.
Data sourced from ClinicalTrials.gov (NCT01879852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.