Multicenter Clinical Observation PROMOS®

• Sponsor: Smith & Nephew Orthopaedics AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02280499
• Collaborator: (none)
• Enrollment: 87
• Duration (Months): 136

Study Details

Study Description

Brief Summary

Overall study design:

This study is a prospective, multicenter, postmarket clinical observation to validate the PROMOS™ Standard Shoulder System as state-of-the-art implant system for total shoulder arthroplasty in terms of radiographic and clinical performance as well as long-term survivorship over 10 years.

Condition or Disease	Intervention/Treatment	Phase
Primary and Secondary Omarthrosis	Device: standard PROMOS prosthesis

Detailed Description

Primary objective:

Radiological and clinical loosening rates of the glenoid and humeral components must be comparable or below the rates of other well documented state-of-the-art shoulder systems with cemented glenoid components. Complications occurring intra- or postoperatively will be assessed and sub-classified in their relation to the implant.

At the end of the observation, a long-term survival rate will be calculated according to Kaplan-Meier with revision due to aseptic loosening as the end-point.

Secondary objectives:

The Constant Murley score and the ASES clinical evaluation are used for documenting the improvement in pain, function and range of motion. For the patient's subjective view of improvement in function a patient self-assessment form is used.

Study Design

• Study Type: Observational
• Actual Enrollment: 87 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multicenter Clinical Observation PROMOS®
• Study Start Date: Nov 1, 2003
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Outcome Measures

Primary Outcome Measures

1. Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components [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.

Secondary Outcome Measures

1. Constant Murley Score [10 Years]

   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.

2. ASES Shoulder Score Index [10Years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patient has no general medical contraindication to surgery

• informed consent to participate in the observation signed by the patient

• routine radiographic assessment is possible

• patient is likely to comply with study follow-up requirements

• primary total- or hemi-shoulder-arthroplasty to the affected side, unilateral or bilateral

Exclusion Criteria:

• acute shoulder trauma

• tumor / malignoma

• avascular necrosis

• late stage rotator cuff disease

• Charcot joint disease or other severe neurosensory deficits

• high comorbidity

• previously failed shoulder arthroplasty

• fracture sequelae of proximal humerus

• hypersensitivity to the implant materials used

• addictive disorders such as alcohol or drug abuse

• severe spinal disorders

• bacterial infections

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Smith & Nephew Orthopaedics AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Smith & Nephew Orthopaedics AG
• ClinicalTrials.gov Identifier: NCT02280499
• Other Study ID Numbers: D8240-1
• First Posted: Oct 31, 2014
• Last Update Posted: Mar 21, 2016
• Last Verified: Feb 1, 2016

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Promos™ Standard Shoulder System
Arm/Group Description	All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
Period Title: Overall Study
STARTED	87
COMPLETED	26
NOT COMPLETED	61

Baseline Characteristics

Arm/Group Title	Promos™ Standard Shoulder System
Arm/Group Description	All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
Overall Participants	87
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.8 (11.4)
Sex: Female, Male (Count of Participants)
Female	58 66.7%
Male	29 33.3%
Body Mass Index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	26.81 (4.45)

Outcome Measures

1. Primary Outcome

Title	Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components
Description	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.
Time Frame	up to 10 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Promos™ Standard Shoulder System
Arm/Group Description	All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
Measure Participants	87
Number (95% Confidence Interval) [Percentage survivorship]	96.29

2. Secondary Outcome

Title	Constant Murley Score
Description	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.
Time Frame	10 Years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Promos™ Standard Shoulder System
Arm/Group Description	All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
Measure Participants	23
Mean (Standard Deviation) [units on a scale]	72.80 (16.89)

3. Secondary Outcome

Title	ASES Shoulder Score Index
Description	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.
Time Frame	10Years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Promos™ Standard Shoulder System
Arm/Group Description	All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
Measure Participants	27
Mean (Standard Deviation) [units on a scale]	76.88 (18.21)

Adverse Events

Arm/Group Title	Promos™ Standard Shoulder System
Arm/Group Description	All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
All Cause Mortality
	Promos™ Standard Shoulder System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Promos™ Standard Shoulder System
	Affected / at Risk (%)	# Events
Total	31/87 (35.6%)
Blood and lymphatic system disorders
Stroke	1/87 (1.1%)
Pulmonary Embolism	1/87 (1.1%)
Heart attack	2/87 (2.3%)
Thrombosis right leg	1/87 (1.1%)
General disorders
Death	14/87 (16.1%)
Infections and infestations
Pneumonia	1/87 (1.1%)
Investigations
Revision of study device	5/87 (5.7%)
Musculoskeletal and connective tissue disorders
Fall - traum. rupture of subscapularis	1/87 (1.1%)
Trauma (abduction and rotation)	1/87 (1.1%)
Migration of humeral component	1/87 (1.1%)
Glenoid loosening	1/87 (1.1%)
Nervous system disorders
Partial Plexus paresis	1/87 (1.1%)
Other (Not Including Serious) Adverse Events
	Promos™ Standard Shoulder System
	Affected / at Risk (%)	# Events
Total	2/87 (2.3%)
Musculoskeletal and connective tissue disorders
Subacromial Impingement	1/87 (1.1%)
No active mobilization after surgery due to pain	1/87 (1.1%)

Limitations/Caveats

One limitation of the study relates to the small number of subjects available at the 10 year interval for final analysis due to the early termination of 2 sites.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.