Correction of Functional Deformity, Fracture of the Humeral Head, Non-inflammatory Degenerative Joint Disease, Revision of the Devices if Sufficient Bone Stock Remains, Rhematoid Arthritis, Traumatic Arthritis
Conditions
Brief summary
This study is a Multi-center, Prospective Follow-up, Non-significant risk, Post-Market Clinical Follow-Up (PMCF) study to Evaluate the Safety and Effectiveness of the Tornier Perform™ Reversed MonoPost System.
Detailed description
It is anticipated that a total of 150 subjects will be enrolled at up to ten sites over a one year enrollment period. The study has been designed to follow the surgeon's standard of care for subjects treated with shoulder arthroplasty with the device including imaging (x-rays and or CT scans). The primary endpoint of this study is to demonstrate pain relief and improved subjects' shoulder functionality by achieving a mean target of 25-points Total ASES Score improvement, for each type of glenoid (two sub cohorts: Standard with/without BIO-RSA and Augmented baseplate) at 2 years follow-up compared to baseline. Secondary objectives are to collect postoperative data on the related clinical complications and functional outcomes of the device to demonstrate the safety and performance of these implants in a real-world setting.
Interventions
DEVICETornier Perform™ Reversed MonoPost
The Commercially available Tornier Perform™ Reversed MonoPost Glenoid is intended to replace the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis.
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
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 (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC). * Willing and able to comply with the requirements of the study protocol * Considered a candidate or having received shoulder arthroplasty with the device, having a functional deltoid muscle and with massive and non-repairable rotator cuff tear with pain disabled by: * Rheumatoid arthritis * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fracture of the Humeral Head * Traumatic arthritis * Revision of the devices if sufficient bone stock remains * Enrollment occurred up to 1 year after date of surgery provided that mandatory data are accessible: including ASES, Constant, and Active ROM.
Exclusion criteria
* Contraindications or hypersensitivity to the use of the Tornier Perform™ Reversed MonoPost System or their components (e.g., metal sensitivity). * Participation in the treatment period of another clinical trial during the clinical investigation. * Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44. Examples include any subject "with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance: American Shoulder and Elbow Surgeons (ASES) score- change in functional ability of the treated shoulder | from baseline to 2 years | The average change in functional ability as measured by the American Shoulder and Elbow Surgeons (ASES) score. ASES is an absolute score ranging from 0 to 100 where a higher score indicates better shoulder function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance: Subject Satisfaction- change in patient satisfaction with their shoulder | from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 2 years | Satisfaction rating collected from patients at baseline, 6 months, and annually. Rating options are: Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied. |
| Performance: Range of Motion | from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 2 years | Active range of motion collected at baseline, 6mths, 1 year and 2 years and any other standard collection timepoint. To evaluate shoulder function, measuring internal and external rotation, forward flexion, extension, and abduction. |
| Safety: Adverse Event rate and assessments | from date of treatment until date of study exit (study completion or early termination for any cause), assessed up to 2 years | Cumulative incidence of procedure and/or device related events |
| Safety: Revision rate and device survivorship | from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 2 years | The cumulative incidence of device revisions and reoperations |
| Performance: Constant-Murley Shoulder score- change in level of pain and ability to carry out normal daily activities of the patient | from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 2 years | Assessed via the Constant-Murley Shoulder score collected at baseline, 6mths, 1 year, 2 years and any other standard collection timepoint. In this score, 35 points are allocated for subjective assessments of pain and activities of daily living and 65 points are available for objective measures of range of movement and shoulder strength. A score of 100 is a healthy shoulder. |
Contacts
CONTACTMonica Fleeman
CONTACTRebecca Gibson
STUDY_DIRECTORRebecca Gibson
Stryker Trauma & Extremities
Outcome results
None listed