Patient Benefit From the New Modular Shoulder Prosthesis PROMOS

Smith & Nephew Orthopaedics AG155 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

155

Conditions

Primary or Secondary Omarthrosis of the Shoulder Joint

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Orthopaedische Praxis / Praxisklinik

Münster, Germany

Schulthess Klinik

Zurich, Switzerland

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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