Degenerative Joint DiseaseNCT05357378
Safety and Effectiveness of the HIT Reverse HRS
A study testing Hip Innovation Technology Reverse Hip Replacement System and Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination. in people with Degenerative Joint Disease and Osteoarthritis, Hip, run by Hip Innovation Technology at 6 sites in United States.
Trial summary
The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Degenerative Joint Disease, Osteoarthritis, Hip, Avascular Necrosis of Hip
- What is being tested?
- Hip Innovation Technology Reverse Hip Replacement System and Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Jul 2022to 16 Sep 2038
- Phase
- Interventional
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requires primary THA due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary THA.
- Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment.
- Patient has preoperative medical clearance and is free from or treated for medical conditions that would pose excessive operative risk.
- Patient has a signed and dated Informed Consent Form (ICF).
- Patient is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires.
Who cannot join
- Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip in the last 24 months.
- Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2 on a Numeric Rating Scale 0-10.
- Patient needs bilateral hip replacement or has a planned THA on the contralateral hip joint in the next 24 months.
- Patient needs knee arthroplasty or has a planned total knee arthroplasty in the next 24 months.
- Patient has a known allergy to titanium and/or XLPE.
- Patient has known metal sensitivities to cobalt chromium (CoCr).
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- Patient has a history of septic arthritis in the index joint.
- Patient has insufficient acetabular or femoral bone stock in which good anchorage of the implants is unlikely or impossible.
- Patient has total or partial absence of the muscular or ligamentous apparatus.
- Patient has known moderate to severe renal insufficiency.
- Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in either leg (based on the Investigator's judgment).
- Patient has a deformity of the affected limb or significant anatomic variance of the affected hip.
- Patient has an active malignancy or history of invasive malignancy within the last 5 years, except for superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix definitively treated more than 1 year prior to enrollment may enter the study.
- Patient has Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.
- Patient has an inflammatory DJD including any of its composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis, and other arthritic processes of inflammatory or autoimmune etiology.
- Patient has any condition that would interfere with self-assessment of pain, function, or quality of life (QoL) required for patient-reported outcomes during the study (based on the Investigator's judgment).
- Patient has a Body Mass Index (BMI) of 40 or higher.
- Patient has an active infection (e.g., hepatitis, Acquired Immune Deficiency Syndrome (AIDS), AIDS-related Complex (ARC)) that is systemic or at the site of the intended surgery.
- Patient is currently participating in any investigational study not related to this study's preoperative or postoperative care.
- Patient is currently pregnant or is planning to become pregnant during the study.
- Patient is a competitive or professional athlete.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 5 recruiting
- Terminated
LifeBridge Health Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, 21215
- Recruiting
Miami Institute for Joint Reconstruction
Miami, Florida, 33186
Lauren Homolka, 239-223-2573, laurenhom11@gmail.com
Arturo Corces
- Recruiting
JIS Orthopedics
New Albany, Ohio, 43054
David A Crawford, MD, 614-221-6331, CrawfordDA@jisortho.com
Michael Sneller, 614-964-0348, snellerma@jisortho.com
- Recruiting
Division of Orthopaedic Surgery
Somers Point, New Jersey, 08244
Stephen Zabinski, 609-226-9560, sjzabinski@comcast.net
Valerie Paul, 609-927-1999, vpaul@shoreorthodocs.com
- Recruiting
Advent Health Hospital, Carrollwood
Tampa, Florida, 33614
Anne Meredith Baldy, 813-910-3693, ambaldy@foreonline.org
Steven Lyons
- Recruiting
Tampa General Health / Florida Orthopedic Institute
Tampa, Florida, 33615
Anne Meredith Baldy, 813-910-3693, ambaldy@foreonline.org
Michael Miranda, DO
About this study
Official title: Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study
The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices.
Read the detailed description
This is a randomized, controlled, multi-center clinical trial. Subjects meeting inclusion and exclusion criteria will be recruited from patients undergoing primary THA at up to 20 investigational sites. Subjects in the Experimental Arm will receive the Investigational Device. Subjects in the Control Arm will receive one of the already-marketed semi constrained uncemented hip systems using a metal on highly cross-linked polyethylene (XLPE) or ceramic-on-XLPE bearing combination. The following hip systems will be eligible for subjects in the Control Arm:
- DePuy Synthes CORAIL® or DePuy Synthes ACTIS™ Total Hip System in combination with DePuy Synthes PINNACLE™ Complete Acetabular Hip System;
- Zimmer Biomet Taperloc®, Zimmer Z1™ Cementless Femoral Hip Stem System or Zimmer Biomet AVENIR® Complete Hip System in combination with Zimmer Biomet G7® Acetabular System;
- Stryker Accolade® II femoral stem in combination with Stryker Trident® II acetabular cup;
- Smith \& Nephew ANTHOLOGY® Total Hip System in combination with Smith \& Nephew R3® Acetabular System.
Surgery, post-surgical care, and rehabilitation will be per standard of care (SOC) for both arms.
- Conditions
- Degenerative Joint Disease, Osteoarthritis, Hip, Avascular Necrosis of Hip, Traumatic Arthropathy-Hip
- Being tested
- Hip Innovation Technology Reverse Hip Replacement System, Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.
- Keywords
- total hip arthroplasty
- Medical subject headings
- Joint Diseases, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip Innovation Technology Reverse Hip Replacement SystemDevice
Also called HIT Reverse HRS
Implantation of the Investigational Device is performed using standard surgical procedures for THA, as described in the Instructions for Use (IFU). The control hip systems will be implanted in accordance with their respective IFU, which are also in line with standard surgical approaches for THA.
Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.Device
Also called DePuy Synthes CORAIL® or DePuy Synthes ACTIS™ Total Hip System in combination with DePuy Synthes PINNACLE™ Complete Acetabular Hip System, Zimmer Biomet Taperloc® or Zimmer Biomet AVENIR® Complete Hip System in combination with Zimmer Biomet G7® Acetabular System, Stryker ACCOLADE® II femoral stem in combination with Stryker TRIDENT® II acetabular cup, Smith & Nephew ANTHOLOGY® Total Hip System in combination with Smith & Nephew R3® Acetabular System
Control Arm subjects will receive one of the already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.
- DePuy Synthes CORAIL® or DePuy Synthes ACTIS™ Total Hip System in combination with DePuy Synthes PINNACLE™Complete Acetabular Hip System.
- Zimmer Biomet Taperloc®, Zimmer Z1™ Cementless Femoral Hip Stem System or Zimmer Biomet AVENIR® Complete Hip System in combination with Zimmer Biomet G7® Acetabular System.
- Stryker Accolade® II femoral stem in combination with Stryker Trident® II acetabular cup.
- Smith \& Nephew ANTHOLOGY® Total Hip System in combination with Smith \& Nephew R3® Acetabular System
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm - HIT Reverse HRS | Experimental | Subjects in the Experimental Arm will receive the HIT Reverse HRS Investigational Device. Implantation of the Investigational Device is performed using standard surgical procedures for THA, as described in the Instructions for Use (IFU). The control hip systems will be implanted in accordance with their respective IFU, which are also in line with standard surgical approaches for THA. Receives: Device: Hip Innovation Technology Reverse Hip Replacement System |
| Control Arm | Active comparator | Subjects in the Control Arm will receive one of the already-marketed semi- constrained uncemented hip systems using a metal-on-highly-cross-linked polyethylene (XLPE) or ceramic-on-XLPE bearing combination. Receives: Device: Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHS of 36 or more at the 2-year follow-up visit
The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).
Measured: 24 months
Change in OHS of 12 or more at the 2-year follow-up visit compared to baseline.
The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).
Measured: 24 months
Radiologic success at the 2-year follow-up
Defined as
- No radiolucencies greater than 2 mm in 50% or more of the cup or stem zones;
- No femoral or acetabular subsidence greater than or equal to 5 mm from baseline;
- No acetabular cup inclination change greater than 4 degrees from baseline.
Measured: 24 months
Absence of revision at the 2-year follow-up visit
No reoperations that led to removal or replacement of any of the acetabular or femoral components.
Measured: 24 months
Secondary outcomes (2)
Change in OHS compared to baseline at all follow-up visits.
The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).
Measured: 24 months
Change in HHS compared to baseline at all follow-up visits.
The Harris Hip Score (HHS) is a clinician-based 10-item questionnaire used to evaluate the results of hip surgery. It is comprised of 4 sub-sections yielding a maximum possible score of 100 points collectively, including pain (44 points), function (47 points), absence of deformity (4 points), and range of motion (5 points).
Measured as Cohen's effect size, the improvements of THA are in the range of 3 and higher (Singh et al., 2016). The traditional categorization of HHS is: < 70, poor; 70-79, fair; 80-89, good; and 90-100, excellent.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start15 Jul 2022
- Primary completion16 Sep 2030 (estimated)
- Study completion16 Sep 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Joint DiseaseStudies 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
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hip Innovation Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357378
- Sponsor's protocol ID
- HIT-002
- Status last verified
- Sep 2026
- First submitted
- 20 Apr 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Singh JA, Schleck C, Harmsen S, Lewallen D. Clinically important improvement thresholds for Harris Hip Score and its ability to predict revision risk after primary total hip arthroplasty. BMC Musculoskelet Disord. 2016 Jun 10;17:256. doi: 10.1186/s12891-016-1106-8.
PubMed 27286675