Phase 2
Completed N=44
Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function
Source: ClinicalTrials.gov NCT00710840 ↗Enrolled (actual)
44
Serious AEs
2.3%
Results posted
May 2015
Primary outcomePrimary: Quadriceps Muscle Force — 1.27; 1.37; 0.79; 0.66 Nm/kg — p=0.07
Summary
Osteoarthritis (OA) is a long-term degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. A procedure called total knee arthroplasty (TKA), in which the affected surface of the knee joint is replaced by plastic or metal, has been successful in restoring comfort and mobility to formerly arthritic joints. This study will compare quadriceps muscle strength, knee range of motion, and pain in people who have had a traditional TKA with those who have had a minimally invasive TKA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quadriceps Muscle Force |
1.27; 1.37; 0.79; 0.66; 1.24; 1.20 | 0.07 |
| PRIMARY Knee Range of Motion |
120.0; 119.3; 98.6; 96.9; 113.5; 112.4 | 0.48 |
| SECONDARY Functional Performance: 6 Minute Walk (6MW) Distance |
464.0; 434.7; 345.9; 326.6; 474.6; 448.5 | 0.92 |
| SECONDARY Functional Performance: Stair Climb Test |
18.1; 19.4; 35.0; 32.2; 15.9; 16.4 | 0.41 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of osteoarthritis
- Eligible for a unilateral or bilateral primary TKA to be performed by Dr. Michael Dayton (University of Colorado Hospital)
- Minimum of 110 degrees of active knee flexion
- No greater than 10 degrees of anatomic knee varus, 15 degrees anatomic valgus, and 10 degrees flexion contracture
- Body mass index less ≤ 40 kg/m2
Exclusion Criteria
- Any brain, circulation, or heart problems that limit function
- Severe osteoarthritis or other orthopedic conditions that limit function in the lower extremity that is not undergoing the TKA
Data sourced from ClinicalTrials.gov (NCT00710840). 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. Informational only — not medical advice.