Anchor Peg - RSA study: stability of a glenoid component

Phase 4

• Conditions: osteoarthritis; shoulderprosthesis; 10005944

• Registration Number: NL-OMON33888
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

· Patient presents with shoulder osteoarthritis and requires a TSP.
· Patient reports moderate to severe pain in affected shoulder.
· Patient is 18 to 80 years of age.
· Patient is in stable health and is free of or treated and stabilized for
cardiac, pulmonary, hematological, or other conditions that would pose
excessive operative risk.

Exclusion Criteria

· Patient diagnosed with posttraumatic osteoarthritis of the shoulder.
· Patient has an active, local infection or systemic infection.
· Patient has a BMI >35.
· Patient has physical, emotional or neurological conditions that would
compromise the patient*s compliance with postoperative rehabilitation
protocol follow-up (e.g.: drug or alcohol abuse, serious mental illness, or
general neurological conditions such as Parkinson, Multiple sclerosis, etc.).
· Patient is pregnant or plans to become pregnant during the course of the RSA
study.
· Patient suffering postoperative complications such as infections,
recurrent luxations, non compliance with normal postoperative care /
rehabilitation program.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified