An observational study in Osteoarthritis, Avascular Necrosis and Rheumatoid Arthritis, sponsored by Zimmer Biomet. Terminated at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Zimmer Biomet · Observational
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Among 101 studies in Osteoarthritis by Zimmer Biomet — 4 open to participants now, 24 under way, none of them phase 3. Osteoarthritis · Zimmer Biomet.
Among the 101 studies in Osteoarthritis by Zimmer Biomet, this one is the 13th largest by enrollment of the 53 observational ones that give a count, is one of 8 that started in 2011, is one of 53 observational ones, and was the 81st registered.
2,974 studies on the registry are indexed under Osteoarthritis; 435 are open to participants now.
Browse Osteoarthritis studies →4 of the 101 studies in Osteoarthritis by Zimmer Biomet are open now, in 8 countries. Recruiting first, the newest first:
Zimmer Biomet · Sites in United States
Ages 18+
Zimmer Biomet · Sites in United States, Australia, Finland and 5 more countries
Ages 18+
Zimmer Biomet · Sites in United States
Ages 18+
Zimmer Biomet · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 285 Osteoarthritis studies recruiting now, 157 (55%) set no upper age limit and 71 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
101 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 8 started in 2011.
This study's enrollment of 223 is above the median of 100 across 601 observational studies indexed under Osteoarthritis.
Median enrollment 133 across the 48 interventional studies, 118 across the 53 observational. Of the 65 that completed or were terminated, 33 (51%) 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.
6 of the studies in Osteoarthritis 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 |
|---|---|
| NCT01480440Zimmer BiometOutcomes Study of the Trabecular Metal (TM) Reverse Shoulder System | 2026-12 |
| NCT03626038Zimmer BiometPost Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System | 2026-12 |
| NCT03404778Zimmer BiometComprehensive Reverse Shoulder Data Collection | 2026-12 |
| NCT02337244Zimmer, GmbHZimmer POLAR Persona - TKA (EMEA Study) | 2026-12 |
| NCT03372278Zimmer BiometPMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty | 2027-01 |
Add all 6 to your calendar (.ics) → With an account.
Among the 101 studies in Osteoarthritis by Zimmer Biomet, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is a multi-center, prospective, non-controlled post-market surveillance study. The primary objective of this study is to confirm the safety and performance of the CLS Brevius stem with Kinectiv technology by obtaining implant survivorship and clinical outcomes data for the commercially available stem.
The CLS Brevius Stem with Kinectiv Technology (also referred to as CLS Brevius Kinectiv Stem) is a straight, cementless stem which is based on the successful anchoring philosophy of the CLS Spotorno Stem. In order to be more bone-conserving, the stem was distally shortened by 20% compared to the CLS Spotorno Stem. To restore individual patients' anatomies more accurately, the CLS Brevius Stems are fused with the existing Zimmer Kinectiv Modular Neck Technology.
The objectives of this study are to confirm the safety and performance of the CLS Brevius Kinectiv Stem when used in primary total hip arthroplasty. Safety will be evaluated by monitoring the frequency and incidence of adverse events. Performance will be determined by analyzing the implant survival, overall pain and functional performances, subject quality-of-life and radiographic parameters of study subjects who received the CLS Brevius Kinectiv Stem.
In addition, metal ion levels (titanium and aluminium) will be analyzed pre-operatively and at 6 months, 1, 2 and 5 years in a subset of 70 to 80 patients (30 to 35%).
The primary endpoint is defined as the implant survival at 10 years. Indication: Patients suffering from severe hip pain and disability requiring total hip arthroplasty and who meet the inclusion/exclusion criteria.
Study design: multi-center, prospective, non-controlled. Length of Study: 12 years (20 months enrollment plus 10 years follow-up): follow-up visits at 6 months, 1,2,3,5,7 and 10 years post-operatively.
A maximum total of 230 patients will be enrolled in the study.
Subjects in need of a total hip arthroplasty, which receive the CLS Brevius Kinectiv stem and who meet all of the inclusion and none of the exclusion criteria.
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.
Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and received the CLS Brevius Kinectiv stem.
Device: CLS Brevius stem with Kinectiv technology
Implant survivorship is assessed counting the number of implant revisions
Time frame: 10 years
Ran from Jan 2011 to primary completion in Apr 2019, 99 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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