Fracture
Conditions
Keywords
Fracture shoulder arthroplasty, Three or four part fracture, Hemiarthroplasty, Multi-center, Europe, Non-controlled, Anatomical reconstruction, Proximal
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
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.
Interventions
PROCEDUREFracture Shoulder Arthroplasty
Implantation of the Anatomical Shoulder Fracture System
Sponsors
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Performance | 5 years | Constant & Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome. |
Countries
Germany, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fracture Device Patient were treated with an Anatomical Shoulder Fracture device.
Fracture Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Fracture System | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | did not receive study device | 1 |
| Overall Study | Lost to Follow-up | 14 |
| Overall Study | Revision | 7 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Fracture Device |
|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 10.4 |
| BMI | 28.4 kg/m2 STANDARD_DEVIATION 8.9 |
| Height | 167.6 cm STANDARD_DEVIATION 10.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Region of Enrollment Germany | 8 participants |
| Region of Enrollment Switzerland | 24 participants |
| Region of Enrollment United Kingdom | 19 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 23 Participants |
| Weight | 79.5 kg STANDARD_DEVIATION 24 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 52 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 20 / 52 |
Outcome results
Primary
Functional Performance
Constant & Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome.
Time frame: 5 years
Population: 22 participants with Constant \& Murley Score between baseline and 5 years follow-up available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fracture Device | Functional Performance | 57.7 score on a scale | Standard Deviation 13.2 |