Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant

NCT03806881 | Enrolling By Invitation

• 1 other identifier: SMAT009
• Study Type: observational
• Target: 24
• Locations: 2 countries
• Sites: 4

Brief Summary

This post-market follow-up study investigates improvement in clinical and radiological outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid Reconstruction system

Conditions

Arthroplasty, Replacement, Shoulder; Glenoid Cavity; Osteoarthritis of the Shoulder

Outcome Measures

Primary Outcomes (1)

• Change in baseline Constant-Murley Score after surgery

  The Constant-Murley score is a clinical outcome scale composed of a number of individual parameters, defining the level of pain, the ability to carry out the normal daily activities of the patient, mobility and strength of the arm. The scores range from 0 (worst clinical outcome) to 100 (best clinical outcome).

  6 weeks, 3 months, 1 year, 2 year, 5 years after surgery

Secondary Outcomes (13)

• Change in baseline Simple Shoulder Test (SST) after surgery

  6 weeks, 3 months, 1 year, 2 year, 5 years after surgery

• Change in baseline Oxford Shoulder Score (OSS) after surgery

  6 weeks, 3 months, 1 year, 2 year, 5 years after surgery

• change in general health EQ5D score after surgery

  6 weeks, 3 months, 1 year, 2 year, 5 years after surgery

• change in baseline pain score using Visual Analogue Scales (VAS) after surgery

  6 weeks, 3 months, 1 year, 2 year, 5 years after surgery

• Translational deviation from planned implant position

  6 weeks after surgery

Study Arms (1)

Treatment group

Patients treated with a Glenius Glenoid Reconstruction System

Device: reversed glenoid prothesis

Interventions

reversed glenoid prothesis DEVICE

All patients will undergo a primary or revision arthroplasty with Glenius according to the routine practice at the investigation site and will be followed at specified visiting moments, during which radiological and clinical data will be gathered.

Also known as: Glenius Glenoid Reconstruction system

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients having primary or revision shoulder joint replacement with severe glenoid bone defects caused by:(1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, (2) Inflammatory degenerative joint disease such as rheumatoid arthritis or (3) Congenital malformations, posttraumatic deformities or removal of components during revision surgery

You may qualify if:

• patients having primary or revision shoulder joint replacement with severe glenoid bone defects
• Patient is 18 years of age or older
• Patient can follow the Glenius system procedure that is standard of care
• Patient is willing to cooperate in the required post-operative therapy
• Patient has participated in the informed consent process and has signed the EC approved informed consent form

You may not qualify if:

• Pregnant patients
• Skeletally immature patients
• Prisoners

Sponsors & Collaborators

• Materialise: lead

Study Sites (4)

AZ St-Elisabeth

Herentals, Belgium

Location

University Hospital Leuven - Traumatology

Leuven, 3000, Belgium

Location

University Hospital Leuven - Orthopedics

Leuven, Belgium

Location

Sint-Maartenskliniek

Nijmegen, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 16, 2019
• Study Start: July 1, 2019
• Primary Completion: October 1, 2024
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); NL (1)