Anatomical Shoulder™ Fracture PMCF Study
- Conditions
- Fracture
- Interventions
- Procedure: Fracture Shoulder Arthroplasty
- Registration Number
- NCT02465398
- Lead Sponsor
- Zimmer Biomet
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Age - 18 years minimum.
- Sex - male and female.
- General Health - the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
- Informed Consent - patient or patient's legal representative has signed a 'Patient Informed Consent form'.
- Indications - Diagnosis of trauma in the affected joint with the indication for shoulder hemiarthroplasty.
-
Patient is skeletally immature.
-
Patient is pregnant.
-
Patient is unwilling or unable to cooperate in a follow-up program.
-
Patient is planned for a bilateral shoulder replacement.
-
Patient shows one or more of the following medical conditions:
- Pathological Fracture
- Active Infection
-
Patient requires one or more of the following medical interventions:
- Revision surgery (non-union)
- Inverse fracture prosthesis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fracture device Fracture Shoulder Arthroplasty Patient were treated with an Anatomical Shoulder Fracture device.
- Primary Outcome Measures
Name Time Method Functional Performance 5 years Constant \& Murley Score
- Secondary Outcome Measures
Name Time Method Survival 5 and 10 years Kaplan-Meier
Trial Locations
- Locations (3)
Klinikum Augsburg
🇩🇪Augsburg, Germany
Uniklinik Balgrist
🇨🇭Zürich, Switzerland
The Pennine Acute Hospital NHS Trust
🇬🇧Manchester, United Kingdom