Overview

This trial is active, not recruiting.

Condition primary or secondary omarthrosis of the shoulder joint
Sponsor Smith & Nephew Orthopaedics AG
Start date June 2009
End date September 2020
Trial size 240 participants
Trial identifier NCT00925496, D10054

Summary

Overall study design:

This study is a prospective, non-randomized, multicenter postmarket clinical follow-up study with two study arms using the two shoulder prosthesis PROMOS™ STANDARD (group A) and PROMOS REVERSE™ (group B). The study will collect efficacy and safety data over 10 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients receiving a standard PROMOS prosthesis
Patients receiving a reverse PROMOS prosthesis

Primary Outcomes

Measure
Primary outcome measures: Patient benefit will be measured with the SPADI and Constant Murley score at the joint level, with the QuickDASH for the upper extremity and the SF-36 mental score as a generic tool.
time frame: Preop / 6M / 1Y / 2Y / 5Y / 10Y

Secondary Outcomes

Measure
Active and passive ROM and strength / Rate of implant related complications / Rate of implant related findings like radiological loosening of the glenoid / Prosthesis survival at common time points, e.g. 5 and 10 years
time frame: Preop / 6M / 1Y / 2Y / 5Y / 10Y

Eligibility Criteria

Male or female participants at least 18 years old.

Eligibility: - Ages eligible for study: minimal age of 18 years - Genders eligible for study: both - Accepts healthy volunteers: no Inclusion Criteria: - Primary or secondary omarthrosis as an indication for primary total shoulder arthroplasty - Massive rotator cuff rupture - Willing an able to give written informed consent to participate in the study including follow-ups Exclusion Criteria: - Previous ipsilateral shoulder arthroplasty (group A and B) - Late stage rotator cuff disease (only group A) - Acute shoulder trauma (group A and B) - General medical contraindication to surgery (group A and B) - Legal incompetence (group A and B) - Tumour / malignoma (group A and B) - Recent history of substance abuse (group A and B) - Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) (group A and B) - Known hypersensitivity to the materials used (group A and B) - Bacterial infection at the time point of operation (group A and B)

Additional Information

Official title Patient Benefit From the New Modular Shoulder Prosthesis PROMOS - a Multicentre Cohort Study
Principal investigator Hans-Kaspar Schwyzer, Dr. med.
Description Primary objective of the study: The primary objective is to quantify patient benefit after primary total shoulder arthroplasty with the modular PROMOS™ shoulder system in a multicenter cohort study (real world approach). Patient benefit will be quantified using objective and validated subjective measures of function, activities of daily living (ADL) and quality of life (QoL). Secondary objectives: - Rate of implant related findings like radiological loosening of the glenoid and complications like intraoperative stem fissures - Prosthesis survival at common time points, e.g. 5 and 10 years
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Smith & Nephew, Inc..