Reduced Knee Flexion Clinical Trial
Official title:
Dynamic Splinting After Total Knee Arthroplasty: a Randomized, Controlled Trial
| NCT number | NCT00857701 |
| Other study ID # | 2008.009 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | March 6, 2009 |
| Last updated | August 8, 2013 |
| Start date | January 2009 |
| Verified date | August 2013 |
| Source | Dynasplint Systems, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for knee flexion contracture following a total knee arthroplasty.
| Status | Terminated |
| Enrollment | 25 |
| Est. completion date | |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Reduced flexibility in AROM of knee extension - Pain that is worsened by bending over while legs are straight - Impaired gait pattern - Ability to understand informed consent and experiment responsibilities Exclusion Criteria: - Fractures - Knee sepsis - Osteomyelitis or any orthopedic infection - Extensor mechanism dysfunction - Psoriasis - Knee joint neuropathy - Previous Stroke or Brain Injury |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Dennis L Armstrong M.D. | Mesa | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Dynasplint Systems, Inc. |
United States,
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* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Maximal Acitive Range of Mothion in knee extension | 9 weeks | No |