TESS Shoulder Arthroplasty Data Collection

A Prospective, Multicentre Study Evaluating the Clinical Performance of the T.E.S.S Anatomic and Reverse Shoulder Prostheses

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00751673

Enrollment

600

Registered

2008-09-12

Start date

2006-01-31

Completion date

2019-10-31

Last updated

2019-10-08

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

Conditions

Arthritis

Brief summary

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

Detailed description

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.

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Change in Constant Murley Score	6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year	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.
Change in Oxford Score	6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year	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.

Secondary

Measure	Time frame	Description
Complications	Any time	General and shoulder specific complicatons are collected any time.
Patient Satisfaction	6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year	Binary question.

Countries

Belgium, France

Outcome results