Trial Outcomes & Findings for A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System (NCT NCT04089371)

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

10 participants

Primary outcome timeframe

24 months

Results posted on

2025-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A Total Shoulder Arthroplasty / Hemiarthroplasty Total Shoulder Arthroplasty (TSA) Humeral \& Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement. ReUnion Total Shoulder Arthroplasty (TSA): The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.	Arm B Reverse Shoulder Arthroplasty Reverse Shoulder Arthroplasty (RSA) Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement ReUnion Reverse Shoulder Arthroplasty (RSA): The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.
Overall Study STARTED	0	10
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A Total Shoulder Arthroplasty / Hemiarthroplasty Total Shoulder Arthroplasty (TSA) Humeral \& Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement. ReUnion Total Shoulder Arthroplasty (TSA): The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.	Arm B Reverse Shoulder Arthroplasty Reverse Shoulder Arthroplasty (RSA) Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement ReUnion Reverse Shoulder Arthroplasty (RSA): The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.
Overall Study Withdrawal by Subject	0	1
Overall Study Study terminated early	0	9

Baseline Characteristics

A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A Total Shoulder Arthroplasty / Hemiarthroplasty Total Shoulder Arthroplasty (TSA) Humeral \& Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement. ReUnion Total Shoulder Arthroplasty (TSA): The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.	Arm B Reverse Shoulder Arthroplasty n=10 Participants Reverse Shoulder Arthroplasty (RSA) Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement ReUnion Reverse Shoulder Arthroplasty (RSA): The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.	Total n=10 Participants Total of all reporting groups
Age, Continuous	—	70.80 years STANDARD_DEVIATION 7.64 • n=7 Participants	70.80 years STANDARD_DEVIATION 7.64 • n=5 Participants
Sex: Female, Male Female	—	9 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	—	10 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · N/A	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	10 participants n=7 Participants	10 participants n=5 Participants
Body Mass Index (BMI)	—	30.62 kg/m² STANDARD_DEVIATION 6.67 • n=7 Participants	30.62 kg/m² STANDARD_DEVIATION 6.67 • n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: No Subjects were enrolled in Arm A. \*Limited Sample Size for Arm B at 24mths, only 2 out of 10 subjects with available data for Arm B.

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.

Outcome measures

Outcome measures
Measure	Arm B Reverse Shoulder Arthroplasty n=2 Participants Reverse Shoulder Arthroplasty (RSA) Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement ReUnion Reverse Shoulder Arthroplasty (RSA): The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.
24-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)	86.50 score on a scale Standard Deviation 4.95

PRIMARY outcome

Timeframe: *12 months (reporting 12mth as more data available)

Population: No Subjects were enrolled in Arm A. \*Limited Sample Size for Arm B at 12mths, only 4 out of 10 subjects with available data for Arm B.

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.

Outcome measures

Outcome measures
Measure	Arm B Reverse Shoulder Arthroplasty n=4 Participants Reverse Shoulder Arthroplasty (RSA) Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement ReUnion Reverse Shoulder Arthroplasty (RSA): The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.
12-month Mean ASES Shoulder Score: Arm B (Reverse Shoulder Arthroplasty)	65.25 score on a scale Standard Deviation 20.82

SECONDARY outcome

Timeframe: 24 mths

Population: No adverse events were reported.

Incidence of intraoperative and post-operative adverse events related to the device will be collected and reported. Time to earliest device-related incident will be analyzed.

Outcome measures

Outcome measures
Measure	Arm B Reverse Shoulder Arthroplasty n=10 Participants Reverse Shoulder Arthroplasty (RSA) Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement ReUnion Reverse Shoulder Arthroplasty (RSA): The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.
Device-related Adverse Events	0 Participants

SECONDARY outcome

Timeframe: 10 years

Population: Due to early study termination, the planned implant survivorship analysis could not be performed; therefore, secondary efficacy/performance could not be assessed. It is to be noted that during the study, no intraoperative nor postoperative AEs were reported, as well as no reported subject deaths, therefore the raw survival for the 10 subjects in Arm B at the time of study closure was 100%.

Time to mortality or last available assessment will be measured and reported.

Outcome measures

Outcome data not reported

Adverse Events

Arm A Total Shoulder Arthroplasty / Hemiarthroplasty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B Reverse Shoulder Arthroplasty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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