An observational study in Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis and Protrusio Acetabuli, sponsored by Zimmer Biomet. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Zimmer Biomet · Observational
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Among 57 studies in Osteonecrosis by Zimmer Biomet — 3 open to participants now, 15 under way, none of them phase 3. Osteonecrosis · Zimmer Biomet.
Among the 57 studies in Osteonecrosis by Zimmer Biomet, this one is the 38th largest by enrollment of the 41 observational ones that give a count, is one of 5 that started in 2023, is one of 41 observational ones, and was the 57th registered.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
Browse Osteonecrosis studies →3 of the 57 studies in Osteonecrosis by Zimmer Biomet are open now, in 4 countries. Recruiting first, the newest first:
Paragon 28 · Sites in United States
Ages 21+
Zimmer Biomet · Sites in United States
Ages 18–80
Zimmer Biomet · Sites in United States, Belgium, Italy and 1 more country
Ages 18–80
By country, each count listing its studies:
Of the 23 Osteonecrosis studies recruiting now, 14 (61%) set no upper age limit and 4 (17%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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57 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 5 started in 2023.
This study's enrollment of 6 is below the median of 121 across 127 observational studies indexed under Osteonecrosis.
Median enrollment 193 across the 16 interventional studies, 118 across the 41 observational. Of the 39 that completed or were terminated, 18 (46%) have results posted.
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Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
3 of the studies in Osteonecrosis by Zimmer Biomet that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03409718Zimmer BiometDatabase Retrieval for the Comprehensive Shoulder | 2026-12 |
| NCT01480440Zimmer BiometOutcomes Study of the Trabecular Metal (TM) Reverse Shoulder System | 2026-12 |
| NCT03372278Zimmer BiometPMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty | 2027-01 |
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Among the 57 studies in Osteonecrosis by Zimmer Biomet, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
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.
The Longevity IT Oblique liner was designed to provide variable joint anteversion and abduction.
Device: Total Hip Arthroplasty with Longevity IT Oblique Liners
The Longevity IT Offset liner was designed to lateralize the center of rotation of the cup.
Device: Total Hip Arthroplasty with Longevity IT Offset Liners
Primary or Revision Total Hip Arthroplasty using the Longevity IT Oblique liners according to the approved indications and compatible device.
Primary or Revision Total Hip Arthroplasty using the Longevity IT Offset liners according to the approved indications and compatible device.
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.
Time frame: 10 years
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
Time frame: 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.
Time frame: 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.
Time frame: 10 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2023 to primary completion in Nov 2024, 14 months.
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This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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