Fracture, Shoulder, Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders
Conditions
Keywords
Osteoarthritis, Fracture, rotator cuff tear, shoulder trauma
Brief summary
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
Detailed description
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices and demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices. To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements. To provide data and analysis for presentations, abstracts, publications and other public release of results. A patient is considered a success at minimum of 2 years post-operative follow-up based upon the following composite clinical success (CCS): * Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline * No continuous radiolucency or device migration/subsidence * No revision surgery * No serious device related adverse event The Registry will continue to follow patients to 10 years post-operative to track survivorship.
Interventions
Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, FXV135 Mini Shoulder System, FXV135 Humelock Shoulder System
Sponsors
FX Shoulder Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system.
Exclusion criteria
Patient who does not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS): | 2 years | Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline. No continuous radiolucency or device migration/subsidence No revision surgery No serious device related adverse event. |
| Survivorship | 10 years | Follow patient's post-operative to track survivorship. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Constant Score | 6 weeks, 3, 6, 12, and 24 months. | The Constant-Murley score (CMS) is a validated 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion (40 points) with the subject completing the assessment prior to the Investigator completing their part of the assessment. The higher the score, the higher the quality of the function. An Adjusted Constant score will be calculated using normalized values to account for age and gender, as based upon anatomical gender at birth. |
| QuickDASH | 6 weeks, 3, 6, 12, and 24 months. | QuickDASH measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level. The higher the score, the higher the function and lower pain in the patient. |
| American Shoulder and Elbow Surgeon (ASES) | 6 weeks, 3, 6, 12, and 24 months | ASES is a validated patient-reported outcome which is composed of 10 functional questions and one pain VAS. The total score is of 100 maximum points and weighted evenly between pain and function |
| Visual Analog Scale (VAS). | 6 weeks, 3, 6, 12, and 24 months | A validated measurement of pain in a patient where 0 indicates no pain and 100 indicates severe pain. The VAS is a straight horizontal line of fixed length. |
| Range of Motion (ROM) | 6 weeks, 3, 6, 12, and 24 months | The patient performs active movements in all functional planes for the shoulder. Includes flexion, extension, abduction, adduction and internal and external rotation. Investigator estimates the range of movement and compares the affected with the unaffected shoulder and the normal expected range. |
| Secondary Surgical Interventions (SSI) | 24 months and at 5 years postoperative | SSI's are re-operations, revisions, and removals. |
| Serious Adverse Event | 24 months and at 5 years postoperative | 1. Led to a death. 2. Resulted in life threatening illness or injury. 3. Resulted in patient hospitalization or prolongation of existing hospitalization. 4. Resulted in patient disability or permanent damage or required intervention to prevent permanent impairment/damage. 5. Led to a congenital abnormality or birth defect. |
| Serious Adverse Device Effects (SADE) | 24 months and at 5 years postoperative. | Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event. |
| Radiographic Reviews and Assessments. | 24 months and at 5 years postoperative. | Monitor implant integrity and signs of implant loosening. |
| Survival | 24 months and at 5 years | Subject disposition. |
Countries
United States
Contacts
CONTACTBrian Wasonga, MHA
CONTACTBrian Rogers, BS
STUDY_DIRECTORKathy Trier, PhD
FX Shoulder Solutions
Outcome results
None listed