Trials / Terminated
TerminatedNCT03260699
Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)
To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- The Cleveland Clinic · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (TKA) surgery needs to be examined. Therefore the investigators questioned whether wearing a brace that has previously been shown to increase strength and function in OA patients can also increase strength and function in patients after TKA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OCSI Rehabilitator brace | Guardian Brace features the innovative Rehabilitator™ line of gait correcting, leg strengthening braces. Rehabilitator™ Knee Braces are clinically proven to reduce UNBRACED pain, strengthen the affected leg, and significantly improve function after only 90 days of brace wear. |
Timeline
- Start date
- 2017-10-05
- Primary completion
- 2018-01-01
- Completion
- 2018-01-01
- First posted
- 2017-08-24
- Last updated
- 2019-10-09
- Results posted
- 2019-08-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03260699. Inclusion in this directory is not an endorsement.