Trial Outcomes & Findings for Anaverse™ Glenoid System and Its Instrumentation (NCT NCT05215600)

Last Updated: 2025-04-08

Results Overview

The primary endpoint of this study is the survival of the implant (Reversed configuration) after 2 years, which is based on removal of the baseplate and will be determined using the Kaplan-Meier method.

Recruitment status

TERMINATED

Target enrollment

20 participants

Primary outcome timeframe

2 years post-op

Results posted on

2025-04-08

Participant Flow

Recruitment was terminated prematurely due to early termination of the study due to product rationalization for commercial reasons. 20 participants (21 cases) of the 30 planned cases were included.

Unit of analysis: Implants

Participant milestones

Participant milestones
Measure	Anaverse Shoulder System Subjects Subjects implanted with the Anaverse Shoulder System in the reversed configuration and subjects who underwent total shoulder arthroplasty conversion from anatomical to reversed. Anaverse Shoulder System: Reverse Shoulder Arthroplasty
Overall Study STARTED	20 21
Overall Study COMPLETED	20 21
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anaverse Shoulder System Subjects n=20 Participants Subjects implanted with the Anaverse Shoulder System in the reversed configuration and subjects who underwent total shoulder arthroplasty conversion from anatomical to reversed. Anaverse Shoulder System: Reverse Shoulder Arthroplasty
Age, Continuous	69.1 years STANDARD_DEVIATION 8.6 • n=20 Participants
Sex: Female, Male Female	11 Participants n=20 Participants
Sex: Female, Male Male	9 Participants n=20 Participants
Region of Enrollment Switzerland	20 Participants n=20 Participants
Height	168.3 cm STANDARD_DEVIATION 10.1 • n=20 Participants
Weight	80.7 kg STANDARD_DEVIATION 16.1 • n=20 Participants

PRIMARY outcome

Timeframe: 2 years post-op

Outcome measures

Outcome measures
Measure	Anaverse Shoulder System Subjects n=21 Implants Subjects implanted with the Anaverse Shoulder System in the reversed configuration and subjects who underwent total shoulder arthroplasty conversion from anatomical to reversed. Anaverse Shoulder System: Reverse Shoulder Arthroplasty
Survival of Implant System (Kaplan Meier)	20 Implants

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-operative (baseline), 1 year, 2 years post-operative

Population: * preoperative and 1-year data was collected retrospectively, therefore number number analyzed in the rows might differ from overall number analyzed * 1 patient completed study participation prior to the 2 years follow-up due to revision surgery

The Constant Murley (CM) Score comprises outcome measures of freedom from pain (15 points), full range of function (20 points), active range of movement (40 points), and full strength (25 points). The total score is an aggregate of the individual outcome measures. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome).

Outcome measures

Outcome measures
Measure	Anaverse Shoulder System Subjects n=21 Implants Subjects implanted with the Anaverse Shoulder System in the reversed configuration and subjects who underwent total shoulder arthroplasty conversion from anatomical to reversed. Anaverse Shoulder System: Reverse Shoulder Arthroplasty
Constant Murley Shoulder Score (CM) Preop	26.5 score on a scale Standard Deviation 13.5
Constant Murley Shoulder Score (CM) 1 year	65.4 score on a scale Standard Deviation 17.0
Constant Murley Shoulder Score (CM) 2 years	71.0 score on a scale Standard Deviation 8.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-operative (baseline), 1 year, 2 years post-operative

The Subjective Shoulder Value (SSV) is a single point, subjective estimate of a patient's condition. The patient is asked to rate the functionality of their operated shoulder on a scale of 0% - 100% of normal.

Outcome measures

Outcome measures
Measure	Anaverse Shoulder System Subjects n=21 Implants Subjects implanted with the Anaverse Shoulder System in the reversed configuration and subjects who underwent total shoulder arthroplasty conversion from anatomical to reversed. Anaverse Shoulder System: Reverse Shoulder Arthroplasty
Subjective Shoulder Value (SSV) Preop	28.3 percentage of normal Standard Deviation 17.5
Subjective Shoulder Value (SSV) 1 year	85.5 percentage of normal Standard Deviation 11.9
Subjective Shoulder Value (SSV) 2 years	85.7 percentage of normal Standard Deviation 14.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediate post-op to 2 years post-operative

Radiographic parameters: X-rays have been evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes (glenoid), component migration (humeral implant subsidence / glenoid component migration), heterotopic ossification and scapular notching

Outcome measures

Outcome measures
Measure	Anaverse Shoulder System Subjects n=21 Implants Subjects implanted with the Anaverse Shoulder System in the reversed configuration and subjects who underwent total shoulder arthroplasty conversion from anatomical to reversed. Anaverse Shoulder System: Reverse Shoulder Arthroplasty
Radiographic Parameters Heterotopic Ossification - Grade 1 · Yes	4 Implants
Radiographic Parameters Heterotopic Ossification - Grade 3-4 · No	21 Implants
Radiographic Parameters Scapular Notching - Grade 1 · Yes	7 Implants
Radiographic Parameters Radiolucency - Humerus ≥ 2mm · Yes	1 Implants
Radiographic Parameters Radiolucency - Humerus ≥ 2mm · No	20 Implants
Radiographic Parameters Radiolucency - Glenoid · Yes	0 Implants
Radiographic Parameters Radiolucency - Glenoid · No	21 Implants
Radiographic Parameters Osteolysis - Humerus ≥ 2mm · Yes	1 Implants
Radiographic Parameters Osteolysis - Humerus ≥ 2mm · No	20 Implants
Radiographic Parameters Osteolysis - Glenoid · Yes	0 Implants
Radiographic Parameters Osteolysis - Glenoid · No	21 Implants
Radiographic Parameters Atrophy · Yes	0 Implants
Radiographic Parameters Atrophy · No	21 Implants
Radiographic Parameters Hypertrophy · Yes	0 Implants
Radiographic Parameters Hypertrophy · No	21 Implants
Radiographic Parameters Osteophytes (Glenoid) · Yes	6 Implants
Radiographic Parameters Osteophytes (Glenoid) · No	15 Implants
Radiographic Parameters Component Migration (humeral implant subsidence / glenoid component migration) · Yes	0 Implants
Radiographic Parameters Component Migration (humeral implant subsidence / glenoid component migration) · No	21 Implants
Radiographic Parameters Heterotopic Ossification - Grade 1 · No	17 Implants
Radiographic Parameters Heterotopic Ossification - Grade 2 · Yes	1 Implants
Radiographic Parameters Heterotopic Ossification - Grade 2 · No	20 Implants
Radiographic Parameters Heterotopic Ossification - Grade 3-4 · Yes	0 Implants
Radiographic Parameters Scapular Notching - Grade 1 · No	14 Implants
Radiographic Parameters Scapular Notching - Grade 2-4 · Yes	0 Implants
Radiographic Parameters Scapular Notching - Grade 2-4 · No	21 Implants

Adverse Events

Anaverse Shoulder System Subjects

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Anaverse Shoulder System Subjects n=20 participants at risk Subjects implanted with the Anaverse Shoulder System in the reversed configuration and subjects who underwent total shoulder arthroplasty conversion from anatomical to reversed. Anaverse Shoulder System: Reverse Shoulder Arthroplasty
Infections and infestations Infection >6 weeks	5.0% 1/20 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 2 years)

Other adverse events

Other adverse events
Measure	Anaverse Shoulder System Subjects n=20 participants at risk Subjects implanted with the Anaverse Shoulder System in the reversed configuration and subjects who underwent total shoulder arthroplasty conversion from anatomical to reversed. Anaverse Shoulder System: Reverse Shoulder Arthroplasty
Renal and urinary disorders Urinary disorder	5.0% 1/20 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 2 years)
Musculoskeletal and connective tissue disorders Intraoperative humeral bone fissure	5.0% 1/20 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 2 years)
Musculoskeletal and connective tissue disorders Traumatic Injury (Not study shoulder)	10.0% 2/20 • Number of events 2 • AEs were collected from the time of surgery until study completion (up to 2 years)
Musculoskeletal and connective tissue disorders Instability - Luxation	5.0% 1/20 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 2 years)

Additional Information

Carina Hafner

Zimmer Biomet

Phone: +41797073093

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60