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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip Innovation Technology Reverse Hip Replacement System | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 24 months |
| Radiologic success at the 2-year follow-up | Defined as
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 months |
| Change in HHS compared to baseline at all follow-up visits. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 10 year |
| Exploratory Endpoints: HHS sub-scores (Pain, Function, Absence of Deformity, Range of Motion) at all follow-up visits. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Diamantoni | Contact | 1-866-832-4471 | g.diamantoni@hit-irh.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Institute for Joint Reconstruction | Recruiting | Miami | Florida | 33186 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27286675 | Background | 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. |
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| Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination. | Device | 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.
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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. |
| 24 months |
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. |
| 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. | 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. | 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. | 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). | 10 year |
| Advent Health Hospital, Carrollwood | Recruiting | Tampa | Florida | 33614 | United States |
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| Tampa General Health / Florida Orthopedic Institute | Recruiting | Tampa | Florida | 33615 | United States |
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| LifeBridge Health Rubin Institute for Advanced Orthopedics | Terminated | Baltimore | Maryland | 21215 | United States |
| Division of Orthopaedic Surgery | Recruiting | Somers Point | New Jersey | 08244 | United States |
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| JIS Orthopedics | Recruiting | New Albany | Ohio | 43054 | United States |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
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