Avascular Necrosis, Correction of Functional Deformity, Fractures Humerus, Osteoarthritis Shoulder, Revision of Other Devices if Sufficient Bone Stock Remains, Rheumatoid Arthritis, Rotator Cuff Tears, Traumatic Arthritis
Conditions
Keywords
Total Shoulder Replacement, Osteoarthritis, Joint Diseases, Musculoskeletal Diseases
Brief summary
This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system in both the anatomic and reversed configurations. Retrospective inclusions are allowed: study patients may be enrolled up to 3 months after date of surgery provided that the necessary pre-operative (baseline) and surgery data are accessible. Follow-up visits conducted from 3-month post-surgery onward must be prospective. The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.
Detailed description
This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system in both the anatomic and reversed configurations. Retrospective inclusions are allowed: study patients may be enrolled up to 3 months after date of surgery provided that the necessary pre-operative (baseline) and surgery data are accessible. Follow-up visits conducted from 3-month post-surgery onward must be prospective. The primary outcome measure will be measured by the average improvement in American Shoulder and Elbow Surgeons (ASES) score from baseline to 24 months. Secondary outcome measures include patient reported outcome measures (PROMs) and standard radiographic findings, including, but not limited to: device migration, component breakage, and bone characteristics. Device revision and adverse events (AEs) will be assessed annually throughout the study. Range of motion and radiographic imaging assessments will also be performed at Years 1, 2, 5 and 10 post-operation.
Interventions
DEVICETornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system is intended for use as: * A replacement of shoulder joints in primary anatomic or in primary reverse * A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. The system also allows for conversion from anatomic to reverse shoulder prosthesis in case of revision.
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older at the time of the informed consent. * Informed and willing to sign an informed consent form approved by IRB or Ethics Committee (EC) (when applicable). * Willing and able to comply with the requirements of the study protocol. * Considered for a candidate for shoulder arthroplasty using the study device * Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements
Exclusion criteria
* Not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times) * Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm). * Active local or systemic infection, sepsis, or osteomyelitis * Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid (reassessed at time of surgery) * Significant injury to the brachial plexus * Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components * Neuromuscular disease (e.g., joint neuropathy) * Patient with known allergy to one of the product materials * Metabolic disorders which may impair bone formation * Patient pregnancy * Planned for two-stage surgery (reassessed at time of surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Improvement from Baseline to last follow-up visit in ASES Score | 24 Month | ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant Score | through study completion, an average of 1 year | A score based on a 100-point scale determined by objective measurements made by the physician in the clinic and subjective values based on pain and activities of daily living reported by the patient. |
| SANE | through study completion, an average of 1 year | Single question that asks the patient to rate their shoulder on a scale from 0 to 100, where 100 is normal. |
| EQ 5-D | through study completion, an average of 1 year | Consists of a 5-question measure where patients rate their health today on a 5-point scale on a 5-dimension scale and a visual analogue scale to measure overall health status. |
| Patient Satisfaction | through study completion, an average of 1 year | Single subjective question "How satisfied are you with your shoulder?" |
| Radiographic Findings | Baseline, 1 year, 2 year, 5 year and 10 year | Images will be reviewed by a single orthopedic surgeon to assess for standard radiographic findings, including, but not limited to: device migration, component breakage, and bone characteristics. |
Countries
United States
Contacts
STUDY_DIRECTORRebecca Gibson
Stryker Trauma and Extremities
Outcome results
None listed