Trial Outcomes & Findings for Anatomical Shoulder™ Fracture PMCF Study (NCT NCT02465398)

Last Updated: 2025-06-12

Results Overview

Constant \& Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

5 years

Results posted on

2025-06-12

Participant Flow

Unit of analysis: Implants

Participant milestones

Participant milestones
Measure	Fracture Device Patient were treated with an Anatomical Shoulder Fracture device. Fracture Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Fracture System
Overall Study STARTED	52 52
Overall Study COMPLETED	22 22
Overall Study NOT COMPLETED	30 30

Reasons for withdrawal

Reasons for withdrawal
Measure	Fracture Device Patient were treated with an Anatomical Shoulder Fracture device. Fracture Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Fracture System
Overall Study Death	7
Overall Study Revision	7
Overall Study did not receive study device	1
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	14

Baseline Characteristics

Anatomical Shoulder™ Fracture PMCF Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fracture Device n=51 Participants Patient were treated with an Anatomical Shoulder Fracture device. Fracture Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Fracture System
Age, Continuous	69.3 years STANDARD_DEVIATION 10.4 • n=99 Participants
Sex: Female, Male Female	28 Participants n=99 Participants
Sex: Female, Male Male	23 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	50 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United Kingdom	19 participants n=99 Participants
Region of Enrollment Switzerland	24 participants n=99 Participants
Region of Enrollment Germany	8 participants n=99 Participants
BMI	28.4 kg/m2 STANDARD_DEVIATION 8.9 • n=99 Participants
Height	167.6 cm STANDARD_DEVIATION 10.1 • n=99 Participants
Weight	79.5 kg STANDARD_DEVIATION 24.0 • n=99 Participants

PRIMARY outcome

Timeframe: 5 years

Population: 22 participants with Constant \& Murley Score between baseline and 5 years follow-up available.

Outcome measures

Outcome measures
Measure	Fracture Device n=22 Implants Patient were treated with an Anatomical Shoulder Fracture device. Fracture Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Fracture System
Functional Performance	57.7 score on a scale Standard Deviation 13.2

Adverse Events

Fracture Device

Serious events: 20 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Fracture Device n=52 participants at risk Patient were treated with an Anatomical Shoulder Fracture device. Fracture Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Fracture System
General disorders Death due to unrelated reasons	13.5% 7/52 • Number of events 7 • AE data was collected over the entire study from surgery date until an average of 5 years Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table
Surgical and medical procedures Revision: conversion to reverse prosthesis	1.9% 1/52 • Number of events 1 • AE data was collected over the entire study from surgery date until an average of 5 years Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table
Musculoskeletal and connective tissue disorders Frozen Shoulder	5.8% 3/52 • Number of events 3 • AE data was collected over the entire study from surgery date until an average of 5 years Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table
Musculoskeletal and connective tissue disorders Intraoperative fracture	3.8% 2/52 • Number of events 2 • AE data was collected over the entire study from surgery date until an average of 5 years Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table
Nervous system disorders Nerve deficit	1.9% 1/52 • Number of events 1 • AE data was collected over the entire study from surgery date until an average of 5 years Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table
Musculoskeletal and connective tissue disorders Subluxation	1.9% 1/52 • Number of events 1 • AE data was collected over the entire study from surgery date until an average of 5 years Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table
Musculoskeletal and connective tissue disorders Heterotopic ossification	3.8% 2/52 • Number of events 2 • AE data was collected over the entire study from surgery date until an average of 5 years Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table
Musculoskeletal and connective tissue disorders Other, not shoulder related complications	15.4% 8/52 • Number of events 8 • AE data was collected over the entire study from surgery date until an average of 5 years Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table

Other adverse events

Adverse event data not reported

Additional Information

Elliott Goff

Zimmer Biomet

Phone: +41 79 222 23 08

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60