Osteoarthritis (OA) of the Hip
Conditions
Brief summary
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.
Interventions
DEVICEReparel Bioactive Sleeve
A non-compressive, photobiomodulating sleeve worn on the leg to reduce postoperative pain and swelling.
DEVICETED Stocking
Standard-of-care gradient compression stocking used after hip replacement.
Sponsors
Reparel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-89 * Undergoing primary unilateral total hip replacement * BMI \< 40 * Able to follow postoperative protocol * English speaking
Exclusion criteria
* Age \<18 or \>90 * Physical inability to use stockings * Allergy to silicone/polyester * Active DVT * History of vascular bypass on operative limb (e.g., Fem-Pop, Fem-Fem) * Inability to comply with post-op/rehab * Lymphedema
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forgotten Joint Score | 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. |
| Pain Score (VAS) | 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. |
| HOOS Jr. Score | 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. |
| VR-12 Score | Postoperative Week 12 | The Veterans RAND 12-Item Health Survey (VR-12) evaluates patient-reported physical and mental health status. |
| HSS Satisfaction Score | Postoperative Week 12 | The Hospital for Special Surgery (HSS) Satisfaction Score assesses patient satisfaction following hip replacement surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Deep Vein Thrombosis | 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. |
| Postoperative Narcotic Use | 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. |
| Study Questionnaire Responses | 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. |
| Leg Swelling (Clinical Evaluation) | 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. |
Countries
United States
Outcome results
None listed