Pain Clinical Trial
— TKROfficial title:
Comparison of Clinical Scales and Quantitative Knee Motion Data in Assessing the Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery
Verified date | September 2016 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
This study is to determine the relevancy of clinical scales for outcome measures as compared
to flexion angle and other gait measures. Clinical outcomes measures in the form of the Knee
Society Score and the WOMAC Score will be obtained from patients. Gait data will also be
obtained from total knee replacement (TKR) patients at pre-operative and post-operative
times. Gait data will be measured on unaffected normal controls as a second baseline.
The hypothesis is that the subjects clinical outcome measures do not accurately reflect gait
dependent outcomes amd functional performance of the total knee replacement.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Healthy - needs unilateral total knee replacement Exclusion Criteria: - Active infection - Autoimmune disease/ parkinson's disease - HIV - psychosocial disorders that would preclude accurate evaluation or substance abuse - allergic to - pregnant - active malignancy |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Healthcare, Deptartment of Orthopaedic Surgery | San Bernardino | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patient before and after surgery | To determine the relevancy of clinical scales for outcome measures as compared to flexion angle and other gait measures. Clinical measures in the form of the Knee Society Score and the WOMAC Score will be obtained from patients. | 36 months | No |
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