Trial Outcomes & Findings for A Post-Market Clinical Evaluation of the ReUnion TSA System (NCT NCT03858517)

Results Overview

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

51 participants

Primary outcome timeframe

24 months

Results posted on

2025-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	51
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	51

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
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

A Post-Market Clinical Evaluation of the ReUnion TSA System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ReUnion TSA System n=51 Participants 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.
Age, Continuous	64.08 years STANDARD_DEVIATION 8.13 • n=99 Participants
Sex: Female, Male Female	26 Participants n=99 Participants
Sex: Female, Male Male	25 Participants n=99 Participants
Race/Ethnicity, Customized Ethnicity · Black or African	2 Participants n=99 Participants
Race/Ethnicity, Customized Ethnicity · Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	46 Participants n=99 Participants
Race/Ethnicity, Customized Ethnicity · Other	2 Participants n=99 Participants
Region of Enrollment United States	51 participants n=99 Participants
Body Mass Index (BMI)	32.29 kg/m² STANDARD_DEVIATION 5.56 • n=99 Participants

PRIMARY outcome

Timeframe: 24 months

Population: The Total ASES Shoulder Score (1 \& 2 year LOCF) was available for 24 subjects

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.

Outcome measures

Outcome measures
Measure	ReUnion TSA System n=24 Participants 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.
American Shoulder and Elbow Surgeons (ASES) Shoulder Score	78.75 score on a scale Standard Deviation 26.19

SECONDARY outcome

Timeframe: 24 mths

Population: 5 out of 51 Subjects with reportable 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 TSA System n=51 Participants 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.
Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative and Post-operative Adverse Events Will be Measured.	5 Participants

SECONDARY outcome

Timeframe: From Baseline to last recorded follow-up (~27 Months)

Population: 2 out of 51 Subjects had this data available.

Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects enrolled who have the ReUnion RFX System.

Outcome measures

Outcome measures
Measure	ReUnion TSA System n=2 Participants 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.
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

Adverse Events

ReUnion TSA System

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ReUnion TSA System n=51 participants at risk 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.
Product Issues Implant breakage/wear, humeral or glenoidal	2.0% 1/51 • From Baseline until study was terminated early (~27 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.
Nervous system disorders Nerve injury, mild (minor motor or sensory loss, or spontaneous recovery)	2.0% 1/51 • From Baseline until study was terminated early (~27 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.
Nervous system disorders Nerve injury, severe (significant motor or sensory loss or requiring surgical revision)	2.0% 1/51 • From Baseline until study was terminated early (~27 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 Rotator cuff tear	2.0% 1/51 • From Baseline until study was terminated early (~27 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 Stiffness	2.0% 1/51 • From Baseline until study was terminated early (~27 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