Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02466321 |
| Other study ID # |
06-U02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2005 |
| Est. completion date |
March 31, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Zimmer Biomet |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™
Inverse/Reverse System by analysis of standard scoring systems and radiographs.
Outcome data will be collected using the following standard scoring systems of which summary
statistics will be provided:
- Constant and Murley Score to evaluate clinical parameters such as range of motion,
power, level of pain and functional ability.
- SF-12 Physical and Mental Health Summary Measures (SF12 Questionnaire) comprising of
twelve questions to assess the subject's physical and mental health status which must be
answered by the patient.
Description:
This is a multi-centre, non-comparative, prospective post-market surveillance study involving
orthopaedic surgeons skilled in shoulder replacement surgery. Each case enrolled will receive
an Anatomical Shoulder™ Inverse/Reverse implant. All system components are CE-marked and
commercially available. Patients will be selected according to the subject selection
criteria.
All patients will undergo pre-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 either 6
weeks or 6 months (according to the hospital's standard care plan) and thereafter at 1, 2, 5
and 10 years post hospital discharge.
There are 5 study centres taking part in this project enrolling in total a maximum of 160
patients.
