Clinical Trial: Anatomical Shoulder™ Fracture Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Anatomical Shoulder™ Fracture Post-Market Surveillance Study

Brief Summary:

The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture System by analysis of standard scoring systems and radiographs.

Outcome data will be collected using the following standard scoring systems:

  • Constant and Murley Score
  • Oxford Shoulder Score
  • EQ-5D (EuroQol)

Detailed Summary:

This is a multi-centre, non-comparative, prospective post-market surveillance study involving surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder Fracture implant. All system components are CE (Conformité Européenne)-marked and commercially available. Patients will be selected according to the subject selection criteria.

All patients will undergo pe-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at 6-12 weeks (x-rays only), at 6 months and annually thereafter for a minimum period of 5 years post hospital discharge. Follow-up evaluation at 10 years post hospital discharge is optional.


Sponsor: Zimmer Biomet

Current Primary Outcome: Functional Performance [ Time Frame: 5 years ]

Constant & Murley Score


Original Primary Outcome: Same as current

Current Secondary Outcome: Survival [ Time Frame: 5 and 10 years ]

Kaplan-Meier


Original Secondary Outcome: Same as current

Information By: Zimmer Biomet

Dates:
Date Received: June 4, 2015
Date Started: August 2006
Date Completion: August 2022
Last Updated: July 11, 2016
Last Verified: July 2016