Patient Benefit From the New Modular Shoulder Prosthesis PROMOS

NCT00925496 | Completed DMC

• 1 other identifier: D10054
• Study Type: observational
• Target: 155
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Primary or Secondary Omarthrosis of the Shoulder Joint

Keywords

Omarthrosis shoulder joint

Outcome Measures

Primary Outcomes (1)

• 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.

  Preop / 6M / 1Y / 2Y / 5Y / 10Y

Secondary Outcomes (1)

• 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

  Preop / 6M / 1Y / 2Y / 5Y / 10Y

Study Arms (2)

Standard PROMOS prosthesis

Patients receiving a standard PROMOS prosthesis

Reverse PROMOS prosthesis

Patients receiving a reverse PROMOS prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (2)

Orthopaedische Praxis / Praxisklinik

Münster, Germany

Location

Schulthess Klinik

Zurich, 8008, Switzerland

Location

Study Officials

• Hans-Kaspar Schwyzer, Dr. med.

  Schulthess Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 22, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 6, 2020

Record last verified: 2020-04

Locations

DE (1); CH (1)