Patient Benefit From the New Modular Shoulder Prosthesis PROMOS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Primary or Secondary Omarthrosis of the Shoulder Joint

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard PROMOS prosthesis

Patients receiving a standard PROMOS prosthesis

No interventions assigned to this group

Reverse PROMOS prosthesis

Patients receiving a reverse PROMOS prosthesis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Genders eligible for study: both
* Accepts healthy volunteers: no

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No