Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate blood flow restriction training as a rehabilitation modalities following total knee arthroplasty in order to determine if patient reported outcomes and objective functional outcomes can be improved through post-operative rehabilitation compared to standard physical therapy modalities currently in use.
Patients will be enrolled preoperatively in order to measure preoperative functional measures. They will then be followed at predetermined intervals post-operatively. All subjects will begin the study related physical therapy 6 weeks post-operatively and continue for 12 sessions. At the conclusion of 12 sessions, subjects will be retested to determine improvement. Subjects will then be followed for two years post-operative.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard physical therapy | Active Comparator | These individuals will conduct physical therapy for 12 sessions as per the institutional standard physical therapy protocol |
|
| Blood flow restriction | Experimental | These individuals will conduct physical therapy for 12 sessions with the addition of blood flow restriction interventions to their standard physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DelfiPTS tourniquet system | Device |
| ||
| Standard physical therapy |
| Measure | Description | Time Frame |
|---|---|---|
| quadriceps strength | quadriceps strength via dynamometer | baseline up to 2 years post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcome 1: KOOS | Patient reported measure of subject pain and function | baseline up to 2 years post operative |
| Patient reported outcome 2: PROMIS Global Health | PROMIS Global Health is a global measure of mental and physical health |
Not provided
Inclusion Criteria:
S/p primary Total Knee Arthroplasty and cleared by surgeon for continued physical therapy
Males and females 50-79 years of age
Ability to consent to study enrollment
Able to participate fully in physical therapy
Tricare Beneficiary
Implant restricted: primary cruciate retaining or posterior stabilized total knee arthroplasty
Knee range of motion of surgical extremity from a minimum of 5 degrees from full extension to 90 degrees of flexion**
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David J Tennent, MD | San Antonio Military Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio Military Medical Center | Fort Sam Houston | Texas | 78234 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
| baseline up to 2 years post operative |
| Patient reported outcome 3: Promis-29 | NIH validated patient reported outcome measure evaluating multiple mental and physical domains | baseline up to 2 years post operative |
| Patient reported outcome 4: Pain Visual analog score | Patient pain rating | baseline up to 2 years post operative |
| Physical Outcome measure 1: Four square step test | Validated functional outcome evaluating lower extremity function | baseline up to 2 years post operative |
| Physical Outcome measure 2: Sit to stand test | Validated functional outcome evaluating lower extremity function | baseline up to 2 years post operative |
| Physical Outcome measure 3: 6 minute walk test | Validated functional outcome evaluating lower extremity function | baseline up to 2 years post operative |
| Physical Outcome measure 4: Timed up and go test | Validated functional outcome evaluating lower extremity function | baseline up to 2 years post operative |
| Physical Outcome measure 5: Timed stair ascent | Validated functional outcome evaluating lower extremity function | baseline up to 2 years post operative |