Sidus(TM) Post Market Clinical Follow-up (PMCF) Study

Status Active, not recruiting

Clinical Trial Summary

This post market clinical follow-up study is designed to confirm safety and performance of the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty. The safety of the implant will be evaluated by monitoring the frequency and incidence of all kinds of adverse events. The performance will be determined by analyzing the implant survival, overall pain and functional performances (based on Constant & Murley score and ASES score), subject quality of life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component migration) of study subjects who received the Sidus Stem-Free Shoulder. The Sidus Stem-Free Shoulder is not approved for use in the US.

Clinical Trial Description

This study is a prospective, noncontrolled, multi-center post market clinical follow-up study involving orthopedic surgeons skilled in hemi and total shoulder arthroplasty procedures. A total number of 160 subjects will be included in the study. Ethics Committee (EC) approval for each site has to be obtained prior to conducting this study. Sequentially, all eligible patients will be offered study enrollment at each center to avoid potential selection bias. All potential subjects will be required to participate in an informed consent process and sign the EC approved written Informed Consent prior to study enrollment. The study is designed to be prospective to ensure that the study population is representative of the type of population that the device is intended to treat. Patients will be selected according to the subject selection criteria described in section 8. All subjects will undergo preoperative, intraoperative and immediate postoperative assessments including physical examinations, radiographic evaluations and collection of quality of life metrics. Follow-up evaluations are to be conducted at 3 and 6 months, 1, 2, 5, 7 and 10 years postoperation. ;

Study Design

Related Conditions & MeSH terms

Arthritis
Arthritis, Rheumatoid
Avascular Necrosis
Inflammatory Joint Disease (IJD)
Joint Diseases
Necrosis
Non-inflammatory Degenerative Joint Disease (NIDJD)
Osteoarthritis
Rheumatoid Arthritis

Clinical Trial Details

NCT number	NCT01700543
Study type	Observational
Source	Zimmer Biomet
Contact
Status	Active, not recruiting
Phase
Start date	October 2012
Completion date	April 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04226131` - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics	N/A
Completed	`NCT04171414` - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis	Phase 3
Completed	`NCT02833350` - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)	Phase 2
Completed	`NCT04255134` - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)	Phase 4
Recruiting	`NCT05615246` - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed	`NCT03248518` - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases	N/A
Completed	`NCT03514355` - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms	N/A
Recruiting	`NCT06005220` - SBD121, a Synbiotic Medical Food for RA Management	N/A
Recruiting	`NCT05451615` - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis	Phase 3
Completed	`NCT05054920` - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis	N/A
Completed	`NCT02037737` - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting	N/A
Recruiting	`NCT04079374` - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel	Phase 3
Completed	`NCT02504268` - Effects of Abatacept in Patients With Early Rheumatoid Arthritis	Phase 3
Recruiting	`NCT05496855` - Remote Care in People With Rheumatoid Arthritis	N/A
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting	`NCT06031415` - Study of GS-0272 in Participants With Rheumatoid Arthritis	Phase 1
Recruiting	`NCT06103773` - A Study of Single and Multiple Oral Doses of TollB-001	Phase 1
Completed	`NCT05999266` - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting	`NCT05302934` - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting	`NCT04169100` - Novel Form of Acquired Long QT Syndrome	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.