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Sponsors and Collaborators: |
Dartmouth-Hitchcock Medical Center Zimmer, Inc. |
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Information provided by: | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00633113 |
The purpose of this study is to evaluate and compare the clinical, radiographic (x-ray) and cost effectiveness outcomes (cost relative to risks and benefits) of two different minimally invasive knee joint replacement surgical techniques. The primary study hypothesis is that in comparing total knee replacement performed with the two different surgical techniques that respect four minimally invasive surgery principles (low-profile instrumentation, "minimally invasive" incision, overall minimal knee surgical intervention), a faster return to function will result when the technique does not incise the tendon.
Condition | Intervention |
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Knee Osteoarthritis |
Procedure: MPPA Procedure: SV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Single Group Assignment, Efficacy Study |
Official Title: | A Randomized, Prospective, Blinded Clinical Trial Comparing Two Total Knee Replacement Techniques |
Estimated Enrollment: | 128 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
- Medial Parapatellar Arthrotomy (MPPA) technique
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Procedure: MPPA
- Medial Parapatellar Arthrotomy
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2: Active Comparator
- Subvastus (SV) technique
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Procedure: SV
- Subvastus Technique
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This study does not include financial compensation for treatments involved.
Ages Eligible for Study: | 35 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: LuAnne A Cori, BA | 603-653-6020 | LuAnne.A.Cori@Dartmouth.edu |
Contact: Jennifer M Scoville, BS | 603-653-3597 | Jennifer.M.Scoville@Dartmouth.edu |
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | Recruiting |
Lebanon, New Hampshire, United States, 03756 | |
Contact: LuAnne A Cori, BA 603-653-6020 LuAnne.A.Cori@Dartmouth.edu | |
Contact: Jennifer M Scoville, BS 603-653-3597 Jennifer.M.Scoville@Dartmouth.edu | |
Principal Investigator: Ivan M Tomek, MD |
Principal Investigator: | Ivan M Tomek, MD | Dartmouth-Hitchcock Medical Center |
Responsible Party: | Dartmouth-Hitchcock Medical Center ( Ivan M. Tomek, M.D. ) |
Study ID Numbers: | MIKRO |
Study First Received: | March 4, 2008 |
Last Updated: | June 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00633113 History of Changes |
Health Authority: | United States: Institutional Review Board |
Total Knee Arthroplasty Minimally Invasive Knee Replacement Knee Osteoarthritis Cost effectiveness minimally invasive knee surgery |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |