Trial Outcomes & Findings for A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System (NCT NCT03880955)

Last Updated: 2025-01-09

Results Overview

This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. 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.

Recruitment status

TERMINATED

Target enrollment

102 participants

Primary outcome timeframe

24 Months

Results posted on

2025-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	ReUnion RSA System Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following: * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis * Failed previous shoulder joint replacement ReUnion RSA System: The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA 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.
Overall Study STARTED	102
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	45

Reasons for withdrawal

Reasons for withdrawal
Measure	ReUnion RSA System Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following: * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis * Failed previous shoulder joint replacement ReUnion RSA System: The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA 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.
Overall Study Adverse Event	1
Overall Study Death	1
Overall Study Lost to Follow-up	12
Overall Study Withdrawal by Subject	4
Overall Study Missing- Study Site Closed	27

Baseline Characteristics

A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ReUnion RSA System n=102 Participants Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following: * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis * Failed previous shoulder joint replacement ReUnion RSA System: The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA 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.
Age, Continuous	69.80 years STANDARD_DEVIATION 8.32 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black or African	6 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	92 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other	4 Participants n=5 Participants
Region of Enrollment United States	102 participants n=5 Participants
Body Mass Index (BMI)	29.49 kg/m² STANDARD_DEVIATION 5.13 • n=5 Participants

PRIMARY outcome

Timeframe: 24 Months

Population: 54 out of 102 Subjects had available data at 24mths.

Outcome measures

Outcome measures
Measure	ReUnion RSA System n=54 Participants Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following: * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis * Failed previous shoulder joint replacement ReUnion RSA System: The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA 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.
American Shoulder and Elbow Surgeons (ASES) Shoulder Score	88.19 units on a scale Standard Deviation 15.39

SECONDARY outcome

Timeframe: 24 months

Population: 4 out of 102 Subjects with reportable Intra-operative Adverse Events. Please see Adverse Events section for break-down.

Secondary outcome measures to assess safety by capturing the incidence rate of device-related intra-operative adverse events.

Outcome measures

Outcome measures
Measure	ReUnion RSA System n=102 Participants Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following: * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis * Failed previous shoulder joint replacement ReUnion RSA System: The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA 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.
Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative Adverse Events.	4 Participants

SECONDARY outcome

Timeframe: 24 months

Population: 16 out of 102 Subjects with reportable post-operative Adverse Events. Please see Adverse Events section for break-down.

Secondary outcome measures to assess safety by capturing the incidence rate of device-related post-operative adverse events.

Outcome measures

Outcome measures
Measure	ReUnion RSA System n=102 Participants Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following: * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis * Failed previous shoulder joint replacement ReUnion RSA System: The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA 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.
Safety Will be Measured by Capturing the Incidence Rate of Device-related Post-operative Adverse Events.	16 Participants

SECONDARY outcome

Timeframe: 24 months

Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects who have the reverse total shoulder endoprosthesis with the ReUnion RSA System.

Outcome measures

Outcome measures
Measure	ReUnion RSA System n=102 Participants Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following: * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis * Failed previous shoulder joint replacement ReUnion RSA System: The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA 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.
Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Reverse Total Shoulder Endoprosthesis With the ReUnion RSA System.	101 Participants

Adverse Events

ReUnion RSA System

Serious events: 0 serious events

Other events: 20 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ReUnion RSA System n=102 participants at risk Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following: * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis * Failed previous shoulder joint replacement ReUnion RSA System: The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA 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.
Infections and infestations Deep infection	2.0% 2/102 • 24 months Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Heterotopic ossification, asymptomatic	4.9% 5/102 • 24 months Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Heterotopic ossification, symptomatic	2.0% 2/102 • 24 months Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Intraoperative fracture of the glenoid	0.98% 1/102 • 24 months Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Intraoperative fracture of the humerus	0.98% 1/102 • 24 months Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Infections and infestations Late infection (e.g. hematogenous or protracted)	0.98% 1/102 • 24 months Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Product Issues Pain related to the implant, severe	0.98% 1/102 • 24 months Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Radiographic lucency, humeral	2.0% 2/102 • 24 months Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Stress fracture of the acromion or the scapular neck	2.9% 3/102 • 24 months Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Skin and subcutaneous tissue disorders Wound complications (e.g. hematoma, wound healing disturbances)	0.98% 1/102 • 24 months Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Other (inferior osteophyte off of glenoid)	0.98% 1/102 • 24 months Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.

Additional Information

Monica Fleeman

Stryker

Phone: 251-465-5969

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place