Osteoarthritis Trial, Recruiting NCT04984291 Sponsor: Zimmer Biomet Condition: Osteoarthritis
Back to Osteoarthritis

Osteoarthritis Trial, Recruiting

NCT04984291
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 20 years of age or older.
  • Your shoulder's physical structure is suitable for receiving a shoulder replacement implant.
  • You need a shoulder replacement for one of these reasons: wear-and-tear arthritis or bone tissue death (avascular necrosis), rheumatoid arthritis, correcting a deformity, a broken upper arm bone where other treatments haven't worked, or a complex shoulder problem where other treatments are not suitable.
  • You are willing and able to attend the required follow-up appointments during the study.
  • You are willing and able to sign the consent form approving your participation.
  • For a specific type of shoulder replacement called a "reverse" implant: the group of muscles that stabilise your shoulder (rotator cuff) is severely damaged or not working, AND you have severe arthritis and/or a previous shoulder replacement that has failed.
  • For the "reverse" implant only: the main muscle that lifts your arm (the deltoid) must still be working.

Who may not be able to join:

  • You are unwilling or unable to give consent or attend follow-up appointments.
  • You have any condition that the study doctor believes could put you at unnecessary risk or interfere with the study.
  • You are currently pregnant or breastfeeding.
  • You are considered a vulnerable person, such as a prisoner, someone unable to understand what the study involves, someone with a known alcohol or drug problem, or someone expected not to follow the study requirements.
  • You have a neurological condition that makes it difficult or impossible to follow instructions or cooperate with the study team.
  • You have any signs of infection in or near your shoulder joint that could spread to the implant.
  • Your X-rays show rapid joint breakdown, significant bone loss, or bone being absorbed by your body.
  • You have a nerve or muscle disease in the affected arm that would make the surgery inappropriate.
  • You have osteoporosis (weak, brittle bones) that your doctor believes would prevent the implant from being properly supported (confirm with trial site).
  • You have osteomalacia (softening of the bones).
  • You have a metabolic condition that interferes with normal bone growth or healing.
  • Your rotator cuff muscles (the group of muscles stabilising the shoulder) are not working — note: this applies to the standard shoulder replacement, not the reverse implant option.
  • You have significant damage to the main nerve network running through your upper arm and shoulder (upper brachial plexus).
  • The nerve that controls your deltoid muscle (axillary nerve) is paralysed.
  • The deltoid muscle or the muscles that rotate your arm outward are not working.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Ryan Boylan, Zimmer Biomet

Phone: 574 268-8610

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Zimmer Biomet
Registry
ClinicalTrials.gov
Start date
28 July 2021
Est. completion
15 August 2033

Where this trial is recruiting

🇯🇵 Japan 🇳🇿 New Zealand 🇺🇸 United States

Primary endpoints

Implant Survivorship at 10 years follow-up (Kaplan Meier); Frequency and Incidence of Adverse Events (Safety)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov