Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function
Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty
3 other identifiers
interventional
44
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2008
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 27, 2008
CompletedFirst Posted
Study publicly available on registry
July 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
May 15, 2015
CompletedJune 10, 2015
March 1, 2015
2.7 years
June 27, 2008
March 18, 2015
May 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quadriceps Muscle Force
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Knee Range of Motion
Knee Flexion Active Range of Motion (AROM)
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Secondary Outcomes (2)
Functional Performance: 6 Minute Walk (6MW) Distance
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Functional Performance: Stair Climb Test
Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
TKA Min is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA Min, as opposed to TKA Traditional, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Colorado Health Sciences Center
Boulder, Colorado, 80304, United States
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size; Relatively short follow-up time
Results Point of Contact
- Title
- Dr. Jennifer Stevens-Lapsley
- Organization
- University of Colorado Denver, Anschutz Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer E. Stevens, MPT, PhD
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
Michael Dayton, MD
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
Wendy Kohrt, PhD
University of Colorado School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2008
First Posted
July 4, 2008
Study Start
June 1, 2008
Primary Completion
February 1, 2011
Study Completion
January 1, 2012
Last Updated
June 10, 2015
Results First Posted
May 15, 2015
Record last verified: 2015-03