Retro-Prospective Postmarket Clinical Study For FX Shoulder Solutions Long Cemented HUMELOCK II®
Trial statusNot yet recruiting
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 HUMELOCK II(r) long cemented humeral stem (shoulder prosthesis) 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 * Constant Score, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Pain score (VAS) 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Indication for hemi anatomic or total reversible shoulder replacement with Long Cemented HUMELOCK II® humeral stem for Trauma or Revision indication, 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/SurgeryHemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Group 1: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Trauma Indications1 intervention
Group B: Group 2: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Revision Indications1 intervention
Group C: Group 3: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Trauma Indications1 intervention
Group D: Group 4: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Revision Indications1 intervention
Trial outcomes
Primary outcomes
1
Revision rate (KM) at 10 years postoperative
Survival rate (%) at 10 years calculated by means of Kaplan-Meier method
Time frame
at the end of the postoperative follow-up period of 10 yearsSecondary outcomes
1
Revision rate (KM) at each postoperative visit
Survival rate (%) at each postoperative visit calculated by means of Kaplan-Meier method
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
Constant-Murley score at each postopererative visit
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The higher the score, the higher the quality of the function and the lower the pain is.
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
ASES score at each postoperative visit
ASES (American Shoulder and Elbow Surgeons) score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function.
Time frame
At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: