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Multicenter Clinical Observation PROMOS®

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ClinicalTrials.gov Identifier: NCT02280499
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )

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
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.

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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Clinical Observation PROMOS®
Study Start Date : November 2003
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015



Primary Outcome Measures :
  1. Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
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
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Responsible Party: Smith & Nephew Orthopaedics AG
ClinicalTrials.gov Identifier: NCT02280499    
Other Study ID Numbers: D8240-1
First Posted: October 31, 2014    Key Record Dates
Results First Posted: March 21, 2016
Last Update Posted: March 21, 2016
Last Verified: February 2016