CClinicalTrials.gg
Active, not recruitingNCT07246200Updated Nov 24, 2025

TED Stocking vs. Reparel Garment After Hip Replacement

An interventional study of Reparel Bioactive Sleeve and TED Stocking in Osteoarthritis (OA) of the Hip, sponsored by Reparel. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by Reparel · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Jan 2022, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
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Study 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.

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Conditions studied

  • Osteoarthritis (OA) of the Hip

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

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Lead sponsor

This is the only study on the registry with Reparel as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Postoperative Weeks 2, 6, and 12

  2. HOOS Jr. Score

    The Hip Disability and Osteoarthritis Outcome Score, Junior (HOOS Jr.) evaluates hip function and patient-reported symptoms following total hip arthroplasty.

    Time frame: Postoperative Weeks 6 and 12

  3. VR-12 Score

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

    Time frame: Postoperative Week 12

  4. HSS Satisfaction Score

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

    Time frame: Postoperative Week 12

  5. 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.

    Time frame: Postoperative Week 12

Secondary outcomes

  1. 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.

    Time frame: Postoperative Weeks 2, 6, and 12

  2. 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.

    Time frame: Up to 12 weeks after surgery

  3. Postoperative Narcotic Use

    Self-reported narcotic medication use will be documented through postoperative questionnaires to compare pain-management differences between intervention assignments.

    Time frame: Collected at 2, 6, and 12 weeks after surgery

  4. Study Questionnaire Responses

    Patients will complete a study-specific questionnaire assessing comfort, usability, perceived swelling, and overall satisfaction with the leg garments.

    Time frame: Weeks 2, 6, and 12 postoperatively

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Study locations

1 site
  • Institute for Joint Restoration
    Fremont, California 94538, United States
08

References and documents

Study documents

  • Study protocol · Dec 1, 2021
  • Informed consent form · Jan 20, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07246200
Lead sponsor
Reparel
Responsible party
Sponsor
First posted
Nov 24, 2025
Start date
Jan 1, 2022
Primary completion
Jan 1, 2024
Completion
Dec 2026 (estimated)
Last update
Nov 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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