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
  Purpose

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.


Condition
Primary or Secondary Omarthrosis of the Shoulder Joint

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Benefit From the New Modular Shoulder Prosthesis PROMOS - a Multicentre Cohort Study

Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: June 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Standard PROMOS prosthesis
Patients receiving a standard PROMOS prosthesis
Reverse PROMOS prosthesis
Patients receiving a reverse PROMOS prosthesis

Detailed 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925496

Locations
Switzerland
Schulthess Klinik
Zurich, Switzerland, 8008
Sponsors and Collaborators
Smith & Nephew Orthopaedics AG
Investigators
Principal Investigator: Hans-Kaspar Schwyzer, Dr. med. Schulthess Klinik
  More Information

No publications provided

Responsible Party: Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )
ClinicalTrials.gov Identifier: NCT00925496     History of Changes
Other Study ID Numbers: D10054
Study First Received: June 19, 2009
Last Updated: March 5, 2014
Health Authority: Switzerland: Ethikkommission
Germany: Ethics Commission

Keywords provided by Smith & Nephew, Inc.:
Omarthrosis shoulder joint

ClinicalTrials.gov processed this record on October 01, 2014