TED Stocking vs. Reparel Garment After Hip Replacement

Evaluation of Standard TED Stocking vs. Reparel Bioactive Garment on Postoperative Leg Swelling, Pain and DVT Rates After Hip Replacement Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis (OA) of the Hip
• Intervention / Treatment: Device: Reparel Bioactive Sleeve; Device: TED Stocking

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Institute for Joint Restoration

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bioactive Sleeve on Operative Leg; Participants receive the Reparel Bioactive Sleeve on the operative leg and the Standard TED Stocking on the non-operative leg.	Device: Reparel Bioactive Sleeve; A non-compressive, photobiomodulating sleeve worn on the leg to reduce postoperative pain and swelling.
Active Comparator: Bioactive Sleeve on Non-Operative Leg; Participants receive the Reparel Bioactive Sleeve on the non-operative leg and the Standard TED Stocking on the operative leg.	Device: TED Stocking; Standard-of-care gradient compression stocking used after hip replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Reparel

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 111225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No