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Zimmer Biomet received the CE mark for the Continuum and Trilogy IT Acetabular System, which includes the Longevity IT Offset and Oblique Liners, in June 2024.
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The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used for primary or revision total hip arthroplasty (implants and instrumentation) at a minimum of 10-year follow-up.
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 1, 3, 5, 7, and 10 years*. The subject devices have been on the market since 2010 but have insufficient data to support 10 years of clinical history. A prospective aspect to the study will be utilized to collect long-term data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Longevity IT Oblique Liners | The Longevity IT Oblique liner was designed to provide variable joint anteversion and abduction. |
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| Longevity IT Offset Liners | The Longevity IT Offset liner was designed to lateralize the center of rotation of the cup. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Arthroplasty with Longevity IT Oblique Liners | Device | Primary or Revision Total Hip Arthroplasty using the Longevity IT Oblique liners according to the approved indications and compatible device. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent Adverse Events (safety) | This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events with particular focus on those that may be related to the study device. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Functional Performance - Oxford Hip Score | "The Oxford Hip Score is patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total hip replacement surgery. Grading the Oxford Hip Score 0 to 19-May indicate severe hip arthritis... 20 to 29-May indicate moderate to severe hip arthritis... 30 to 39-May indicate mild to moderate hip arthritis... 40 to 48-May indicate satisfactory joint function..." Oxford Hip Score. (n.d.) Segen's Medical Dictionary. (2011). Retrieved August 19 2022 from https://medical-dictionary.thefreedictionary.com/Oxford+Hip+Score |
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Inclusion Criteria:
Exclusion Criteria:
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The study population should be a consecutive series of subjects implanted with the Longevity IT Oblique and/or Offset liners in either primary or revision THA. Up to 52 implanted hips with the Oblique liners and up to 52 implanted hips with the Offset liners will be included in the study.
The study population for primary statistical analysis will be comprised of males and females who satisfy the inclusion/exclusion criteria outlined in the protocol. To avoid potential selection bias, each Investigator will offer study participation to each consecutive eligible patient presenting as a potential candidate. Eligible candidates who express interest in study participation will be offered Informed Consent.
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Overholser | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
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| Total Hip Arthroplasty with Longevity IT Offset Liners | Device | Primary or Revision Total Hip Arthroplasty using the Longevity IT Offset liners according to the approved indications and compatible device. |
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| 10 years |
| Performance and Clinical Benefits - Harris Hip Score | Patient Assessment: reported Harris Hip Score (if available) Harris Hip Score: The HHS is divided into three sections. The first section questions is about pain and its impact, which are answered by the patient or client. The second and third sections require the physiotherapist to assess the patient or client's hip joint and function. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. | 10 years |
| Performance and Clinical Benefits - Activity Level | Patient Assessment: activity level Records patient's activity level on a 10-point scale from 'wholly inactive' to 'regularly particpates in impact sports. | 10 years |
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D060048 | Slipped Capital Femoral Epiphyses |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D004839 | Epiphyses, Slipped |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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