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Active, Not Recruiting

NCT Number: NCT07246200

TED Stocking vs. Reparel Garment After Hip Replacement

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Joint Restoration

Fremont, California, 94538, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reparel Bioactive Sleeve

Device

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

TED Stocking

Device

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

Primary outcomes

  1. Pain Score (VAS)

    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.

  2. HOOS Jr. Score

    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.

  3. VR-12 Score

    Time frame: Postoperative Week 12

    The Veterans RAND 12-Item Health Survey (VR-12) evaluates patient-reported physical and mental health status.

  4. HSS Satisfaction Score

    Time frame: Postoperative Week 12

    The Hospital for Special Surgery (HSS) Satisfaction Score assesses patient satisfaction following hip replacement surgery.

  5. Forgotten Joint Score

    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.

Secondary outcomes

  1. Leg Swelling (Clinical Evaluation)

    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.

  2. Incidence of Deep Vein Thrombosis

    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.

  3. Postoperative Narcotic Use

    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.

  4. Study Questionnaire Responses

    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.

Sponsors and collaborators

Lead sponsor

Reparel

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

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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