Multicenter Clinical Observation PROMOS®

NCT ID: NCT02280499

Last Updated: 2016-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2015-03-31

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.

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.

Conditions

Primary and Secondary Omarthrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

standard PROMOS prosthesis

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew Orthopaedics AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

D8240-1

Identifier Type: -

Identifier Source: org_study_id