Clinical trial NCT00925496: Patient Benefit From the New Modular Shoulder Prosthesis PROMOS
Official title: Patient Benefit From the New Modular Shoulder Prosthesis PROMOS - a Multicentre Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary or Secondary Omarthrosis of the Shoulder Joint
Keywords: Omarthrosis shoulder joint
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-22
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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

Eligibility 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)

Primary outcomes:
measure: 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.
timeFrame: Preop / 6M / 1Y / 2Y / 5Y / 10Y
Secondary outcomes:
measure: 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
timeFrame: Preop / 6M / 1Y / 2Y / 5Y / 10Y
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Orthopaedische Praxis / Praxisklinik
city: Zurich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik
name: Hans-Kaspar Schwyzer, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: