Osteoarthritis (OA) of the HipNCT07246200
TED Stocking vs. Reparel Garment After Hip Replacement
A study testing Reparel Bioactive Sleeve and TED Stocking in people with Osteoarthritis (OA) of the Hip, run by Reparel at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Osteoarthritis (OA) of the Hip
- What is being tested?
- Reparel Bioactive Sleeve and TED Stocking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-89
- Undergoing primary unilateral total hip replacement
- BMI < 40
- Able to follow postoperative protocol
- English speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Joint Restoration
Fremont, California, 94538
About this study
Official title: 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.
- Conditions
- Osteoarthritis (OA) of the Hip
- Being tested
- Reparel Bioactive Sleeve, TED Stocking
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reparel Bioactive SleeveDevice
A non-compressive, photobiomodulating sleeve worn on the leg to reduce postoperative pain and swelling.
TED StockingDevice
Standard-of-care gradient compression stocking used after hip replacement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: TED Stocking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Postoperative Week 12
HSS Satisfaction Score
The Hospital for Special Surgery (HSS) Satisfaction Score assesses patient satisfaction following hip replacement surgery.
Measured: 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.
Measured: Postoperative Week 12
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 2, 6, and 12 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jan 2022
- Primary completion1 Jan 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reparel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246200
- Sponsor's protocol ID
- 111225
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Standard TED Stocking vs. Reparel Bioactive Garment on Postoperative Leg Swelling, Pain and DVT Rates After Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT07246200
- Acronym / sponsor ID
- 111225
- Conditions
- Osteoarthritis (OA) of the Hip
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ReparelIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive Sleeve on Operative Leg | Experimental | Device: Reparel Bioactive SleeveParticipants receive the Reparel Bioactive Sleeve on the operative leg and the Standard TED Stocking on the non-operative leg. |
| Bioactive Sleeve on Non-Operative Leg | Active comparator | Device: TED StockingParticipants receive the Reparel Bioactive Sleeve on the non-operative leg and the Standard TED Stocking on the operative leg. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-89
- Undergoing primary unilateral total hip replacement
- BMI < 40
- Able to follow postoperative protocol
- English speaking
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reparel Bioactive SleeveA non-compressive, photobiomodulating sleeve worn on the leg to reduce postoperative pain and swelling. | Device | Bioactive Sleeve on Operative Leg |
| TED StockingStandard-of-care gradient compression stocking used after hip replacement. | Device | Bioactive Sleeve on Non-Operative Leg |
Primary outcome
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.
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.
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.
HSS Satisfaction Score
Time frame: Postoperative Week 12
The Hospital for Special Surgery (HSS) Satisfaction Score assesses patient satisfaction following hip replacement surgery.
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.
4 secondary outcomes
Leg Swelling (Clinical Evaluation)
Time frame: Postoperative Weeks 2, 6, and 12
Incidence of Deep Vein Thrombosis
Time frame: Up to 12 weeks after surgery
Postoperative Narcotic Use
Time frame: Collected at 2, 6, and 12 weeks after surgery
Study Questionnaire Responses
Time frame: Weeks 2, 6, and 12 postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reparel Bioactive Sleeve and TED Stocking in people with Osteoarthritis (OA) of the Hip, run by Reparel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (VAS) (time frame: Postoperative Weeks 2, 6, and 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.