An interventional study of DelfiPTS tourniquet system and Standard physical therapy in Total Knee Arthroplasty and Osteoarthritis, sponsored by San Antonio Military Medical Center. Status unknown at 1 site in United States. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-16.
Sponsored by San Antonio Military Medical Center · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →San Antonio Military Medical Center is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Knee range of motion of surgical extremity from a minimum of 5 degrees from full extension to 90 degrees of flexion**
Exclusion Criteria:
These individuals will conduct physical therapy for 12 sessions as per the institutional standard physical therapy protocol
Other: Standard physical therapy
These individuals will conduct physical therapy for 12 sessions with the addition of blood flow restriction interventions to their standard physical therapy
Device: DelfiPTS tourniquet system
quadriceps strength
quadriceps strength via dynamometer
Time frame: baseline up to 2 years post operative
Patient reported outcome 1: KOOS
Patient reported measure of subject pain and function
Time frame: 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
Time frame: 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
Time frame: baseline up to 2 years post operative
Patient reported outcome 4: Pain Visual analog score
Patient pain rating
Time frame: baseline up to 2 years post operative
Physical Outcome measure 1: Four square step test
Validated functional outcome evaluating lower extremity function
Time frame: baseline up to 2 years post operative
Physical Outcome measure 2: Sit to stand test
Validated functional outcome evaluating lower extremity function
Time frame: baseline up to 2 years post operative
Physical Outcome measure 3: 6 minute walk test
Validated functional outcome evaluating lower extremity function
Time frame: baseline up to 2 years post operative
Physical Outcome measure 4: Timed up and go test
Validated functional outcome evaluating lower extremity function
Time frame: baseline up to 2 years post operative
Physical Outcome measure 5: Timed stair ascent
Validated functional outcome evaluating lower extremity function
Time frame: baseline up to 2 years post operative
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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San Antonio Military Medical Center