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CompletedNCT00925496PromosUpdated Apr 6, 2020

Patient Benefit From the New Modular Shoulder Prosthesis PROMOS

An observational study in Primary or Secondary Omarthrosis of the Shoulder Joint, sponsored by Smith & Nephew Orthopaedics AG. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-06.

Sponsored by Smith & Nephew Orthopaedics AG · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
155
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Primary or Secondary Omarthrosis of the Shoulder Joint

Keywords

  • Omarthrosis shoulder joint
03

In context

Lead sponsor

Smith & Nephew Orthopaedics AG is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic

Eligibility:

  • Ages eligible for study: minimal age of 18 years
  • Genders eligible for study: both
  • Accepts healthy volunteers: no

Inclusion criteria

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
155 participants (actual)

Groups and cohorts

  • Standard PROMOS prosthesis

    Patients receiving a standard PROMOS prosthesis

  • Reverse PROMOS prosthesis

    Patients receiving a reverse PROMOS prosthesis

06

What researchers measure

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.

    Time frame: 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

    Time frame: Preop / 6M / 1Y / 2Y / 5Y / 10Y

07

Study locations

2 sites
  • Orthopaedische Praxis / Praxisklinik
    Münster, Germany
  • Schulthess Klinik
    Zurich, 8008, Switzerland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00925496
Lead sponsor
Smith & Nephew Orthopaedics AG
Responsible party
Sponsor
First posted
Jun 22, 2009
Start date
Jun 2009
Primary completion
Dec 2019
Completion
Dec 2019
Last update
Apr 6, 2020

Study contacts

Hans-Kaspar Schwyzer, Dr. med.
principal investigator · Schulthess Klinik

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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