Back to resultsAnatomical Shoulder™ Fracture PMCF Study
Primary Purpose
Fracture
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Fracture Shoulder Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Fracture focused on measuring Fracture shoulder arthroplasty, Three or four part fracture, Hemiarthroplasty, Multi-center, Europe, Non-controlled, Anatomical reconstruction, Proximal
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Klinikum Augsburg
- Uniklinik Balgrist
- The Pennine Acute Hospital NHS Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Fracture device
Arm Description
Patient were treated with an Anatomical Shoulder Fracture device.
Outcomes
Primary Outcome Measures
Functional Performance
Constant & Murley Score
Secondary Outcome Measures
Survival
Kaplan-Meier
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02465398
Brief Title
Anatomical Shoulder™ Fracture PMCF Study
Official Title
Anatomical Shoulder™ Fracture Post-Market Surveillance Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture
Keywords
Fracture shoulder arthroplasty, Three or four part fracture, Hemiarthroplasty, Multi-center, Europe, Non-controlled, Anatomical reconstruction, Proximal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fracture device
Arm Type
Other
Arm Description
Patient were treated with an Anatomical Shoulder Fracture device.
Intervention Type
Procedure
Intervention Name(s)
Fracture Shoulder Arthroplasty
Intervention Description
Implantation of the Anatomical Shoulder Fracture System
Primary Outcome Measure Information:
Title
Functional Performance
Description
Constant & Murley Score
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Survival
Description
Kaplan-Meier
Time Frame
5 and 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliott Goff, PhD
Organizational Affiliation
Zimmer Biomet, Jr. Clinical Project Lead
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Uniklinik Balgrist
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
Facility Name
The Pennine Acute Hospital NHS Trust
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Anatomical Shoulder™ Fracture PMCF Study
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