Knee Osteoarthritis Clinical Trial
Official title:
Comparison of Different TKAs Using Objective Dynamic Functional Analysis
The purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | November 2022 |
Est. primary completion date | November 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects who have been appropriately designated for treatment with a primary total knee arthroplasty - Subjects who are willing to participate and are willing to sign the Informed Consent/HIPPA documents. Exclusion Criteria: - Subjects who are unsuitable candidates for the two types of knee implants under investigation. - Subjects with significant deformities or arthritis that might affect the procedural decision making, expected outcomes and functions are total knee arthroplasty. - Subjects with significant comorbidities that might be at an increased risk of post-operative complications. - Subjects who are unwilling to sign Informed Consent/HIPAA documents. - Subjects who cannot perform the required activities after the surgery. |
Country | Name | City | State |
---|---|---|---|
United States | Desert Orthopaedic Center | Las Vegas | Nevada |
Lead Sponsor | Collaborator |
---|---|
Russell Nevins, M.D. | MicroPort Orthopedics Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee Injury and Osteoarthritis Outcome Score | KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms | pre-operatively | |
Primary | Knee Injury and Osteoarthritis Outcome Score | KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms | 6 weeks post-operatively | |
Primary | Knee Injury and Osteoarthritis Outcome Score | KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms | 3 months post-operatively | |
Primary | Force generated by operative extremity - walking | Distribution of maximum force between implanted and non- implanted leg during walking | pre-operatively | |
Primary | Force generated by operative extremity - walking | Distribution of maximum force between implanted and non- implanted leg during walking | 6 weeks post-operatively | |
Primary | Force generated by operative extremity - walking | Distribution of maximum force between implanted and non- implanted leg during walking | 3 months post-operatively | |
Primary | Force generated by operative extremity - standing from seated position | Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair | pre-operatively | |
Primary | Force generated by operative extremity - standing from seated position | Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair | 6 weeks post-operatively | |
Primary | Force generated by operative extremity - standing from seated position | Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair | 3 months post-operatively | |
Primary | Force generated by operative extremity - squatting to a seated position | Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position | pre-operatively | |
Primary | Force generated by operative extremity - squatting to a seated position | Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position | 6 weeks post-operatively | |
Primary | Force generated by operative extremity - squatting to a seated position | Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position | 3 months post-operatively | |
Primary | Force generated by operative extremity - walking up stairs | Distribution of maximum force between implanted and non- implanted leg during walking up stairs | pre-operatively | |
Primary | Force generated by operative extremity - walking up stairs | Distribution of maximum force between implanted and non- implanted leg during walking up stairs | 6 weeks post-operatively | |
Primary | Force generated by operative extremity - walking up stairs | Distribution of maximum force between implanted and non- implanted leg during walking up stairs | 3 months post-operatively |
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