Patient Benefit From the New Modular Shoulder Prosthesis PROMOS (Promos)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )
ClinicalTrials.gov Identifier:
NCT00925496
First received: June 19, 2009
Last updated: March 5, 2014
Last verified: March 2014

June 19, 2009
March 5, 2014
June 2009
September 2020   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00925496 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Patient Benefit From the New Modular Shoulder Prosthesis PROMOS
Patient Benefit From the New Modular Shoulder Prosthesis PROMOS - a Multicentre Cohort Study

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.

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinic

Primary or Secondary Omarthrosis of the Shoulder Joint
Not Provided
  • Standard PROMOS prosthesis
    Patients receiving a standard PROMOS prosthesis
  • Reverse PROMOS prosthesis
    Patients receiving a reverse PROMOS prosthesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
December 2020
September 2020   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00925496
D10054
Yes
Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )
Smith & Nephew Orthopaedics AG
Not Provided
Principal Investigator: Hans-Kaspar Schwyzer, Dr. med. Schulthess Klinik
Smith & Nephew, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP