Osteoarthritis Trial, Recruiting NCT07520721 Sponsor: Spaarne Gasthuis Condition: Osteoarthritis
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Osteoarthritis Trial, Recruiting

NCT07520721
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:

  • People of any gender who are 18 years of age or older
  • People with a life expectancy of more than 5 years
  • People who have had painful shoulder osteoarthritis for more than 1 year and have already tried non-surgical treatments without sufficient relief
  • People whose doctors have determined, based on physical examination, medical history, and X-rays, that a primary shoulder replacement is needed in one or both shoulders
  • People with good bone quality, as assessed by the trial investigator
  • People whose shoulder joint fits a specific pattern on imaging (classified as Walch type A1, A2, or B1, with the shoulder socket tilted back no more than 15 degrees) (confirm with trial site)
  • People who are willing and able to attend all scheduled follow-up appointments as outlined in the study consent form
  • People who have been fully informed about the study and have signed the approved consent form

Who may not be able to join:

  • People who need a revision (repeat) shoulder replacement, rather than a first-time replacement
  • People who have osteoporosis with a history of fractures that occurred without a significant injury
  • People who have had steroid injections in the affected shoulder within the past 6 months
  • People who have had a shoulder replacement on the opposite side within the past 3 months
  • People who have significant bone loss or large cysts in the area of the shoulder where the implant would be placed
  • People with a proven or suspected infection in the target shoulder, or any serious infectious disease
  • People with significant nerve or muscle disorders that may affect recovery
  • People with a known or suspected allergy to the metals or other materials used in the implant
  • People who are unwilling or unable to follow the rehabilitation programme or attend follow-up visits, including due to alcoholism, physical infirmity, or a psychiatric condition that would prevent understanding of the study
  • People with a systemic (whole-body) disease that may affect the outcome of the procedure
  • People with active cancer or cancer that has spread to other parts of the body
  • People who have received chemotherapy or radiation therapy within the past 6 months
  • People who have previously had an organ transplant
  • People currently participating in another clinical research study that may interfere with this one
  • People with a current or past diagnosis of schizophrenia, delusional disorder, schizoaffective disorder, a psychotic disorder, or bipolar disorder
  • People with a current substance use disorder (not including nicotine or tobacco use), or moderate to severe alcohol use disorder
  • People considered to be at imminent risk of suicide
  • People with any other psychiatric condition that the study doctors determine makes participation unsuitable

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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Spaarne Gasthuis
Registry
ClinicalTrials.gov
Start date
30 June 2025
Est. completion
30 July 2035

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Constant-Murley Score (shoulder function)

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