TED Stocking vs. Reparel Garment After Hip Replacement

NCT07246200 | Active Not Recruiting FDA Device

• 1 other identifier: 111225
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis (OA) of the Hip

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (4)

• Leg Swelling (Clinical Evaluation)

  Postoperative Weeks 2, 6, and 12

• Incidence of Deep Vein Thrombosis

  Up to 12 weeks after surgery

• Postoperative Narcotic Use

  Collected at 2, 6, and 12 weeks after surgery

• Study Questionnaire Responses

  Weeks 2, 6, and 12 postoperatively

Study Arms (2)

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.

Device: Reparel Bioactive Sleeve

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.

Device: TED Stocking

Interventions

Reparel Bioactive Sleeve DEVICE

A non-compressive, photobiomodulating sleeve worn on the leg to reduce postoperative pain and swelling.

Bioactive Sleeve on Operative Leg

TED Stocking DEVICE

Standard-of-care gradient compression stocking used after hip replacement.

Bioactive Sleeve on Non-Operative Leg

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-89
• Undergoing primary unilateral total hip replacement
• BMI \< 40
• Able to follow postoperative protocol
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Reparel: lead

Study Sites (1)

Institute for Joint Restoration

Fremont, California, 94538, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 24, 2025
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)