Patient Benefit From the New Modular Shoulder Prosthesis PROMOS

Patient Benefit From the New Modular Shoulder Prosthesis PROMOS - a Multicentre Cohort Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00925496

Acronym

Promos

Enrollment

155

Registered

2009-06-22

Start date

2009-06-30

Completion date

2019-12-31

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary or Secondary Omarthrosis of the Shoulder Joint

Keywords

Omarthrosis shoulder joint

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Germany, Switzerland

Outcome results