Patient Benefit From the New Modular Shoulder Prosthesis PROMOS (Promos)

Smith & Nephew

Status: Completed

Conditions: Primary or Secondary Omarthrosis of the Shoulder Joint

Study type: Observational

Funder types: Industry

Identifiers

NCT00925496

D10054

Details and patient eligibility

About

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.

Full 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

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

155 participants in 2 patient groups

Standard PROMOS prosthesis

Description:

Patients receiving a standard PROMOS prosthesis

Reverse PROMOS prosthesis

Description:

Patients receiving a reverse PROMOS prosthesis