An interventional study of 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 Degenerative Joint Disease, Osteoarthritis, Hip and Avascular Necrosis of Hip, sponsored by Hip Innovation Technology. Recruiting at 6 sites in United States. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Hip Innovation Technology · Not applicable, Interventional, and Treatment
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.
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:
Surgery, post-surgical care, and rehabilitation will be per standard of care (SOC) for both arms.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's planned enrollment of 288 is above the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Hip Innovation Technology is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Compared within Osteoarthritis, Hip, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Joint Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Hip Innovation Technology Reverse Hip Replacement System
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.
Device: Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.
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.
Also known as: HIT Reverse HRS
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
Also known as: 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, Zimmer Z1™ Cementless Femoral Hip Stem System
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 24 months
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).
Time frame: 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.
Time frame: 24 months
Exploratory Endpoints: OHS 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).
Time frame: 10 year
Exploratory Endpoints: HHS sub-scores (Pain, Function, Absence of Deformity, Range of Motion) 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.
Time frame: 10 year
Exploratory Endpoints: Device survivorship
Device survivorship is measured as a cardinal event. Any reoperation in which the entire device or part of the device has been removed or replaced will be defined as a device revision.
Time frame: 10 year
Exploratory Endpoints: Radiographic evaluation of linear penetration of the femoral head at the 2-year follow-up visit.
This study requires anteroposterior (AP)-pelvis and lateral (frog-leg or Lauenstein position) views obtained in the supine position on all subjects. An additional AP-hip image will be needed only if the AP-pelvis cannot provide a complete implant image. Radiographs will be obtained at the immediate postoperative follow-up (AP-pelvis only), and at the 6-week, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, and 10-year follow-up visits. Radiographs will be transferred to the Central Radiology Lab for processing and evaluation by an independent radiologist.
Time frame: 10 year
Exploratory Endpoints: Metal ion level assessment of titanium, cobalt, and chromium.
All subjects will have baseline metal ion level (Ti, Co, and Cr) identified before study THA. Further, all subjects will be monitored for metal ions (Ti, Co, and Cr) at 1-, 2-, 3-, 4-, 5-, 7-, and 10-year follow-up visits.
Time frame: 10 year
Exploratory Endpoints: Subject Satisfaction with Outcome.
Subject Satisfaction with Outcome will be evaluated at the 1, 2-, 3-, 4- 5-, 7- and 10-year follow-up visits using a 4-point ordinal scale. The questionnaire will ask subjects how satisfied they are with the outcome of the surgery. The available answers will include: Very Satisfied (4); Somewhat Satisfied (3); Somewhat Dissatisfied (2); and Very Dissatisfied (1).
Time frame: 10 year
Not enrolling at this site.
Plan to share: No
Started Jul 2022 (actual). Primary completion is estimated for Sep 2030, 98 months after the start.
Of 226 interventional studies with no phase under Osteoarthritis, Hip, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 51. This study's planned 98 months is above that.
How these figures are worked out, and which studies are left out of them.
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