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Clinical Trials/NL-OMON47760
NL-OMON47760
Completed
Not Applicable

A multicentre, prospective clinical study analysing outcomes of shoulder arthroplasty with SMR STEMLESS - SMR Stemless

AMSA0 sites50 target enrollmentTBD
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Conditionsosteoarthritis of the shouldercuff tear arthropathy1002321310005944

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
osteoarthritis of the shoulder
Sponsor
AMSA
Enrollment
50
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

Investigators

Sponsor
AMSA

Eligibility Criteria

Inclusion Criteria

  • •\- Patient is requiring primary unilateral or bilateral anatomic or reverse
  • •arthroplasty based on physical examination and medical history;
  • •\- Good bone quality evaluated by the Investigator on the basis of a risk
  • •factors analysis (included MORES/SCORE questionnaires) and the intraoperative
  • •evaluation;
  • •\- A diagnosis in the target shoulder of one or more of the following:
  • •Primary osteoarthritis;
  • •Secondary osteoarthritis;
  • •Post\-traumatic arthritis;
  • •Rheumatoid arthritis;

Exclusion Criteria

  • •\- Patient requiring revision shoulder arthroplasty;
  • •\- Osteoporosis with a history of non\-traumatic fractures;
  • •\- Steroid injections within the previous 3 months;
  • •\- Contralateral shoulder replacement within the previous 3 months;
  • •\- Extensive avascular necrosis (radiologically more than 20%);
  • •\- Meta\-epiphyseal bony defect (including large cysts);
  • •\- Post\-traumatic tuberosity non\-union;
  • •\- Ongoing septicaemia;
  • •\- Significant proven or suspicious infection of the target shoulder or any
  • •serious infectious disease before the study according to the Investigator;

Outcomes

Primary Outcomes

Not specified

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