Institute for Joint Restoration
Fremont, California, 94538, United States
NCT Number: NCT07246200
This randomized, prospective study compares the effectiveness of a novel bioactive garment (Reparel Leg Sleeve) versus standard TED compression stockings in reducing postoperative leg swelling, pain, and deep vein thrombosis (DVT) rates following total hip arthroplasty. The study aims to determine whether the bioactive garment improves patient comfort and recovery outcomes compared to traditional stockings.
This study is active but is not currently recruiting participants.
Notify Me18 year–89 year
All sexes
Interventional
Not applicable
Fremont, California, 94538, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A non-compressive, photobiomodulating sleeve worn on the leg to reduce postoperative pain and swelling.
Standard-of-care gradient compression stocking used after hip replacement.
Time frame: Postoperative Weeks 2, 6, and 12
Pain will be measured using the Visual Analog Scale (VAS), a standard 0-10 numeric rating scale. Patients will report pain levels during routine postoperative follow-up visits or via validated questionnaires.
Time frame: Postoperative Weeks 6 and 12
The Hip Disability and Osteoarthritis Outcome Score, Junior (HOOS Jr.) evaluates hip function and patient-reported symptoms following total hip arthroplasty.
Time frame: Postoperative Week 12
The Veterans RAND 12-Item Health Survey (VR-12) evaluates patient-reported physical and mental health status.
Time frame: Postoperative Week 12
The Hospital for Special Surgery (HSS) Satisfaction Score assesses patient satisfaction following hip replacement surgery.
Time frame: Postoperative Week 12
The Forgotten Joint Score measures the extent to which patients are aware of their hip joint during daily activities, reflecting functional recovery.
Time frame: Postoperative Weeks 2, 6, and 12
Leg swelling will be assessed during routine postoperative clinic visits through standard clinical evaluation, including circumferential measurement and visual assessment for edema.
Time frame: Up to 12 weeks after surgery
Deep vein thrombosis (DVT) occurrence will be monitored through standard postoperative care, including clinical evaluation and diagnostic testing if symptoms suggest DVT.
Time frame: Collected at 2, 6, and 12 weeks after surgery
Self-reported narcotic medication use will be documented through postoperative questionnaires to compare pain-management differences between intervention assignments.
Time frame: Weeks 2, 6, and 12 postoperatively
Patients will complete a study-specific questionnaire assessing comfort, usability, perceived swelling, and overall satisfaction with the leg garments.
Reparel
Industry
Evaluation of Standard TED Stocking vs. Reparel Bioactive Garment on Postoperative Leg Swelling, Pain and DVT Rates After Hip Replacement Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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