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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioactive Sleeve on Operative Leg | Experimental | Participants receive the Reparel Bioactive Sleeve on the operative leg and the Standard TED Stocking on the non-operative leg. |
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| Bioactive Sleeve on Non-Operative Leg | Active Comparator | Participants receive the Reparel Bioactive Sleeve on the non-operative leg and the Standard TED Stocking on the operative leg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reparel Bioactive Sleeve | Device | A non-compressive, photobiomodulating sleeve worn on the leg to reduce postoperative pain and swelling. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Score (VAS) | 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. | Postoperative Weeks 2, 6, and 12 |
| HOOS Jr. Score | The Hip Disability and Osteoarthritis Outcome Score, Junior (HOOS Jr.) evaluates hip function and patient-reported symptoms following total hip arthroplasty. | Postoperative Weeks 6 and 12 |
| VR-12 Score | The Veterans RAND 12-Item Health Survey (VR-12) evaluates patient-reported physical and mental health status. | Postoperative Week 12 |
| HSS Satisfaction Score | The Hospital for Special Surgery (HSS) Satisfaction Score assesses patient satisfaction following hip replacement surgery. | Postoperative Week 12 |
| Forgotten Joint Score | The Forgotten Joint Score measures the extent to which patients are aware of their hip joint during daily activities, reflecting functional recovery. | Postoperative Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Leg Swelling (Clinical Evaluation) | Leg swelling will be assessed during routine postoperative clinic visits through standard clinical evaluation, including circumferential measurement and visual assessment for edema. | Postoperative Weeks 2, 6, and 12 |
| Incidence of Deep Vein Thrombosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Joint Restoration | Fremont | California | 94538 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2021 | Nov 13, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2023 | Nov 13, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| TED Stocking | Device | Standard-of-care gradient compression stocking used after hip replacement. |
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Deep vein thrombosis (DVT) occurrence will be monitored through standard postoperative care, including clinical evaluation and diagnostic testing if symptoms suggest DVT. |
| Up to 12 weeks after surgery |
| Postoperative Narcotic Use | Self-reported narcotic medication use will be documented through postoperative questionnaires to compare pain-management differences between intervention assignments. | Collected at 2, 6, and 12 weeks after surgery |
| Study Questionnaire Responses | Patients will complete a study-specific questionnaire assessing comfort, usability, perceived swelling, and overall satisfaction with the leg garments. | Weeks 2, 6, and 12 postoperatively |