Multicenter Clinical Observation PROMOS®

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.

Study Overview

• Status: Completed
• Conditions: Primary and Secondary Omarthrosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 87

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Murley Score	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.	10 Years
ASES Shoulder Score Index	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.	10Years

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: October 30, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Estimate): March 21, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: D8240-1