TED Stocking vs. Reparel Garment After Hip Replacement

NCT ID: NCT07246200

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis (OA) of the Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Reparel Bioactive Sleeve

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

TED Stocking

Intervention Type DEVICE

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

Interventions

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TED Stocking

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

Intervention Type DEVICE

Reparel Bioactive Sleeve

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reparel

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute for Joint Restoration

Fremont, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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111225

Identifier Type: -

Identifier Source: org_study_id

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