Long-term outcomes after shoulder revision with Comprehensive Revision Stems
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive® Primary Revision Stems (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
This follow-up will see if Comprehensive Revision Stems used in adult shoulder replacements remain safe and perform well at 1, 3, 5, 7, and 10 years after implantation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 59 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06788717 on ClinicalTrials.gov |
What this trial studies
This post-market follow-up combines retrospective and prospective consecutive case series to collect long-term safety and performance data for the Comprehensive Primary Revision Stems. Implant survivorship will be determined by recording the incidence of revisions, complications, and adverse events and specifying whether events relate to the implant, instrumentation, or procedure. Performance will be measured with patient-reported outcome measures and radiographic assessments at predefined intervals of 1, 3, 5, 7, and 10 years. Eligible adults must have had the device implanted according to the surgical technique and IFU and be able to provide informed consent and attend follow-up visits at participating centers.
Who should consider this trial
Good fit: Adults (≥18) who received the Comprehensive Revision Stem per the manufacturer's instructions, can provide informed consent, and are willing to attend scheduled follow-ups are ideal candidates.
Not a fit: Patients with off-label device use, those unable to consent or follow directions (including prisoners, active substance abusers, or those with significant cognitive or psychiatric impairments), or those seeking other experimental therapies are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could confirm the long-term durability and safety of the revision stems and help clinicians and patients make informed implant choices.
How similar studies have performed: Similar post-market follow-up programs for joint replacement implants have previously documented survivorship trends and changes in patient-reported outcomes, though device-specific results vary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Patient must be 18 years of age or older. * Patient must be willing and able to follow directions. * Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem Exclusion Criteria * Off-label use. * Patient is a prisoner. * Patient is a current alcohol or drug abuser. * Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent. * Patient is unwilling to sign informed consent. * Uncooperative patient or patient with neurologic disorders who are incapable of following directions.
Where this trial is running
Los Angeles, California and 1 other locations
- Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
Study contacts
- Study coordinator: Octavia Gladden
- Email: octavia.gladden@zimmerbiomet.com
- Phone: 7044930178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.