TESS Shoulder Arthroplasty Data Collection

Zimmer Biomet600 enrolled

Overview

This observational study intends to collect efficacy and safety data on TESS shoulder system

The T.E.S.S.® shoulder system has been developed to provide a complete solution for all the indications for Shoulder Arthroplasty, Arthritis, Rotator Cuff Arthropathy, Proximal Humeral Fracture, minimising bone resection and restoring the natural anatomy of the patient.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A pre-operative level of pain and function the same as for conventional joint replacement * A likelihood of obtaining relief of pain and improved function * Full skeletal maturity * Ability to follow instructions * Good general health for age * Willing to return for follow-up evaluations Exclusion Criteria: * Glenohumeral joint infection, osteomyelitis * Neuro-muscular complications * Inability to co-operate with and complete the study

Locations (13)

De Dreef Van Zonnebos 13

Schilde, Belgium

Clinique Générale

Annecy, France

Institut Calot

Berck, France

Polyclinique Jean Villar

Outcomes

Primary Outcomes

Change in Constant Murley Score

Improvement in this score will be collected at every follow-up visit.This is a 100-point score, containing 8 questions. Higher score indicate a better outcome.

Time frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year

Change in Oxford Score

Improvement in this score will be collected at every follow-up visit.This is a 60-point score, containing 12 questions. Higher score indicate a better outcome.

Time frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year

Secondary Outcomes

Complications

General and shoulder specific complicatons are collected any time.

Time frame: Any time

Patient Satisfaction

Binary question.

Time frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year

Data from ClinicalTrials.gov

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