Trial Outcomes & Findings for Multicenter Clinical Observation PROMOS® (NCT NCT02280499)

NCT ID: NCT02280499

Last Updated: 2016-03-21

Results Overview

The long-term survival rate of the Promos™ Standard shoulder system was calculated with revision due to aseptic loosening as endpoint using a Kaplan-Meier Analysis.

• Recruitment status: COMPLETED
• Target enrollment: 87 participants
• Primary outcome timeframe: up to 10 years
• Results posted on: 2016-03-21

Participant Flow

93 patients were assessed for eligibility. Two participants were excluded before receiving the intervention due to not meeting the inclusion criteria. Four enrolled subjects did not receive a PROMOS™ prosthesis due to different reasons but were changed to another shoulder implant which was not part of the study.

Participant milestones

Measure	Promos™ Standard Shoulder System All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
Overall Study STARTED	87
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	61

Reasons for withdrawal

Measure	Promos™ Standard Shoulder System All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
Overall Study Death	14
Overall Study Lost to Follow-up	42
Overall Study Adverse Event	5

Baseline Characteristics

Multicenter Clinical Observation PROMOS®

Baseline characteristics by cohort

Measure	Promos™ Standard Shoulder System n=87 Participants All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
Age, Continuous	67.8 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Body Mass Index	26.81 kg/m2 STANDARD_DEVIATION 4.45 • n=5 Participants

PRIMARY outcome

Timeframe: up to 10 years

The long-term survival rate of the Promos™ Standard shoulder system was calculated with revision due to aseptic loosening as endpoint using a Kaplan-Meier Analysis.

Outcome measures

Measure	Promos™ Standard Shoulder System n=87 Participants All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components	96.29 Percentage survivorship Interval 85.43 to 99.1

SECONDARY outcome

Timeframe: 10 Years

Population: As per the study flow chart, 26 study participants had a 10 year follow-up visit to collect the data supporting the primary outcome measure. The Constant Murley Score was incomplete for 3 participants and therefore the number of participants analyzed is 23.

The Constant Murley Score is a shoulder outcome score to determine the functionality of the shoulder after the treatment of a shoulder injury. The score ranges from 0 to 100 with a higher score indicating better shoulder function.

Outcome measures

Measure	Promos™ Standard Shoulder System n=23 Participants All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
Constant Murley Score	72.80 units on a scale Standard Deviation 16.89

SECONDARY outcome

Timeframe: 10Years

Population: As per the study flow chart, 26 study participants had a 10 year follow-up visit to collect the data supporting the primary outcome measure. The ASES Shoulder Score Index was calculated for 27 participants. As the score is a patient reported outcome the score could be completed at home increasing the number of available scores.

The American Shoulder and Elbow Surgeon's (ASES) evaluation is used to document the improvement in pain, function and range of motion after shoulder injury. The ASES Shoulder Score Index is calculated from the ASES patient related questionnaire and ranges from 0-100 with a higher score indicating improvement in pain and function.

Outcome measures

Measure	Promos™ Standard Shoulder System n=27 Participants All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
ASES Shoulder Score Index	76.88 units on a scale Standard Deviation 18.21

Adverse Events

Promos™ Standard Shoulder System

Serious events: 31 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Promos™ Standard Shoulder System n=87 participants at risk All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
Nervous system disorders Partial Plexus paresis	1.1% 1/87
Musculoskeletal and connective tissue disorders Fall - traum. rupture of subscapularis	1.1% 1/87
Musculoskeletal and connective tissue disorders Total shoulder arthroplasty contralateral side	1.1% 1/87
Blood and lymphatic system disorders Stroke	1.1% 1/87
Blood and lymphatic system disorders Pulmonary Embolism	1.1% 1/87
Blood and lymphatic system disorders Heart attack	2.3% 2/87
Musculoskeletal and connective tissue disorders Trauma (abduction and rotation)	1.1% 1/87
Infections and infestations Pneumonia	1.1% 1/87
Musculoskeletal and connective tissue disorders Migration of humeral component	1.1% 1/87
Blood and lymphatic system disorders Thrombosis right leg	1.1% 1/87
Musculoskeletal and connective tissue disorders Glenoid loosening	1.1% 1/87
General disorders Death	16.1% 14/87
Investigations Revision of study device	5.7% 5/87

Other adverse events

Measure	Promos™ Standard Shoulder System n=87 participants at risk All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
Musculoskeletal and connective tissue disorders Subacromial Impingement	1.1% 1/87
Musculoskeletal and connective tissue disorders No active mobilization after surgery due to pain	1.1% 1/87

Additional Information

Evita Leiber, Clinical Study Manager

Smith & Nephew

Phone: +41 41 766 2205

Email: evita.leiber@smith-nephew.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place