Health Trials

RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS

ConditionsHumeral Fracture, ProximalGlenohumeral OsteoarthritisAvascular Necrosis of the Head of HumerusRotator Cuff TearRotator Cuff ArthropathyInflammatory ArthritisRevision of a Shoulder Prosthesis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFX Solutions

About this trial

This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS.

The included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term.

Secondary objectives are

* Revision rate at each post op visit * Range of motion at each post op visit * Quick Dash, Constant, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV), Pain scores at each post op visit * Radiological assessment of implant positioning through geometrical parameters at each post op visit * Incidence of complications at each post op visit * Qualitative feedback from surgeons on the instrumentation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Indication for hemi or total shoulder replacement with one of the FX SHOULDER SOLUTIONS Shoulder Systems, according to its IFU and surgical technique.

Patient aged 18 years and above

Patient insured with a social security system

Has been informed and did consent to participate to the study.

Disqualifiers

Neurological pathologies compromising the shoulder stability

Morbid obesity

Muscular deficiencies impairing the shoulder joint

Trial population

Study population is issued from investigators' patient population.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Shoulder arthroplasty

    Procedure/Surgery

    Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.

Treatment groups

1,004 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Group 1: HUMELOCK II® TSA1 intervention
Group B: Group 21: cementless HUMELOCK II® RSA - trauma1 intervention
Group C: Group 22: cemented long HUMELOCK II® RSA - revision1 intervention
Group D: Group 31: SHUMELOCK REVERSED® - degenerative1 intervention
Group E: Group 32: HUMELOCK REVERSED® - trauma1 intervention
Group F: Group 4: cementless HUMERIS® Anatomic - degenerative1 intervention
Group G: Group 5: cementless HUMERIS® RSA - degenerative1 intervention
Group H: Group 6: EASYTECH® TSA - degenerative1 intervention
Group I: Group 7: EASYTECH® RSA - revision1 intervention
Group J: Group 8: EASYTECH® RSA - degenerative1 intervention
Group K: Group 33: HUMELOCK REVERSED® - revision1 intervention

Trial outcomes

Primary outcomes

1

Revision rate (KM) at 10 years postoperative

Time frame
at the end of the postoperative follow-up period of 10 years

Secondary outcomes

1

Revision rate (KM) at each post-operative visits

Time frame
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)
2

Range of Motions at each postoperative visit

Time frame
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
3

QuickDASH score at each follow-up visit

Time frame
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
4

Constant-Murley score at each follow-up visit

Time frame
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

FX Solutions

Lead sponsor

Source ClinicalTrials.gov
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