Shoulder Arthroplasty
Conditions
Brief summary
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.
Detailed description
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion TSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion TSA System will be demonstrated through reporting of device-related intra-operative and post-operative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter up to 10 years following the index procedure.
Interventions
DEVICEReUnion TSA System
The ReUnion TSA System is designed as an anatomical total shoulder or hemi-shoulder endoprosthesis to address advanced arthritic disorders affecting the shoulder joint in subjects having intact or repairable rotator cuff function. The ReUnion TSA System consists of a completely modular shoulder platform including a Humeral Stem, Humeral Head and Glenoid. The intended purposes of the ReUnion TSA System are to achieve pain relief, improvement of range of motion and restoration or improvement of the shoulder function while ensuring long-term replacement of the shoulder joint with sufficient stability of all endoprosthesis components.
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Subject is willing to sign the informed consent. * Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations. * Subject is male or non-pregnant female and 18 years or older at the time of surgery. * Subject has one or more of the following: * Aseptic necrosis of the humeral head * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis * Failed previous total shoulder replacement, resurfacing or other procedure
Exclusion criteria
* Subject has an active or suspected latent infection in or about the shoulder joint. * Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care. * Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. * Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation. * Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself. * Subject has absent, irreparable or non-functioning rotator cuff and other essential muscles. * Subject has concomitant disease(s) which may significantly affect the clinical outcome. * Subject has traumatic or pathologic fracture of the proximal humerus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Shoulder Score | 24 months | The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative and Post-operative Adverse Events Will be Measured. | 24 mths | Secondary outcome measures to assess safety by capturing the incidence rate of device-related intra-operative adverse events. |
| Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Total or Partial Prosthesis With Full or Partial Implant Survival. | From Baseline to last recorded follow-up (~27 Months) | Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects enrolled who have the ReUnion RFX System. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ReUnion TSA System Subject with one or more of the following diagnoses will be treated with the ReUnion TSA System:
* Aseptic necrosis of the humeral head
* Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
* Failed previous total shoulder replacement, resurfacing or other procedure
ReUnion TSA System: The ReUnion TSA System is designed as an anatomical total shoulder or hemi-shoulder endoprosthesis to address advanced arthritic disorders affecting the shoulder joint in subjects having intact or repairable rotator cuff function. The ReUnion TSA System consists of a completely modular shoulder platform including a Humeral Stem, Humeral Head and Glenoid. The intended purposes of the ReUnion TSA System are to achieve pain relief, improvement of range of motion and restoration or improvement of the shoulder function while ensuring long-term replacement of the shoulder joint with sufficient stability of all endoprosthesis components. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | removed for being incarcerated | 1 |
| Overall Study | Sponsor Closure | 48 |
Baseline characteristics
| Characteristic | ReUnion TSA System |
|---|---|
| Age, Continuous | 64.08 years STANDARD_DEVIATION 8.13 |
| Body Mass Index (BMI) | 32.29 kg/m² STANDARD_DEVIATION 5.56 |
| Race/Ethnicity, Customized Ethnicity Black or African | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 46 Participants |
| Race/Ethnicity, Customized Ethnicity Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 2 Participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 5 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Time frame: 24 months
Population: The Total ASES Shoulder Score (1 \& 2 year LOCF) was available for 24 subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReUnion TSA System | American Shoulder and Elbow Surgeons (ASES) Shoulder Score | 78.75 score on a scale | Standard Deviation 26.19 |
Secondary
Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Total or Partial Prosthesis With Full or Partial Implant Survival.
Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects enrolled who have the ReUnion RFX System.
Time frame: From Baseline to last recorded follow-up (~27 Months)
Population: 2 out of 51 Subjects had this data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReUnion TSA System | Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Total or Partial Prosthesis With Full or Partial Implant Survival. | 750.24 days | Standard Deviation 37.09 |
Secondary
Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative and Post-operative Adverse Events Will be Measured.
Secondary outcome measures to assess safety by capturing the incidence rate of device-related intra-operative adverse events.
Time frame: 24 mths
Population: 5 out of 51 Subjects with reportable Adverse Events. Please see Adverse Events section for break-down.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ReUnion TSA System | Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative and Post-operative Adverse Events Will be Measured. | 5 Participants |