Multicenter Clinical Observation PROMOS®
|ClinicalTrials.gov Identifier: NCT02280499|
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
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|
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.
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|
|Actual Enrollment :||87 participants|
|Official Title:||Multicenter Clinical Observation PROMOS®|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
- 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.
- 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.
- 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.