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

Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant: A Prospective Cohort Study

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Osteoarthritis of the Shoulder; Arthroplasty, Replacement, Shoulder; Glenoid Cavity
• Intervention / Treatment: Device: reversed glenoid prothesis

Detailed Description

The Glenius glenoid implant is a solution for patients who need a reversed glenoid reconstruction (primary or revision) because of a severely damaged glenoid associated with severe bone loss. In these cases, standard reconstruction of the glenoid is not possible because of the lack of body support of the glenoid rim or columns.

The Glenius implant is custom-made prothesis: during pre-operative planning, the implant is designed based on a detailed 3D CT analysis of the defect with special reference to bone quality and the anatomy of the bone deficient glenoid. Optimized screw fixation trajectories are defined for each individual patient, which accommodate screws that are positioned and angled towards the best bone stock available in the glenoid/coracoid/scapula with each specific patient. The surgeon provides feedback on the the design and orientation of the implant needed to achieve the optimal inclination of the head and the position & offset of the joint's centre of rotation.

Because Glenius is a relatively new product and only for use in specific and complex cases of severy glenoid erosion, follow-up data on the clinical and radiological outcome are scarce. With this study we aim to collect long-term clinical and radiological follow-up data for patients treated with Glenius in a uniform, standardized way.

• Study Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

Study Locations

• Belgium
  • Herentals, Belgium
    • AZ St-Elisabeth
  • Leuven, Belgium
    • University Hospital Leuven - Orthopedics
  • Leuven, Belgium, 3000
    • University Hospital Leuven - Traumatology
• Netherlands
  • Nijmegen, Netherlands
    • Sint-Maartenskliniek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnant patients
• Skeletally immature patients
• Prisoners

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment group; Patients treated with a Glenius Glenoid Reconstruction System	Device: reversed glenoid prothesis; 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.; Other Names: Glenius Glenoid Reconstruction system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in baseline Simple Shoulder Test (SST) after surgery	The SST is a function scale with 12 items, used to assess improvement in shoulder function after treatment interventions and to check the patient's ability to tolerate or perform 12 activities of daily living. The scores range from 0 (worst functional outcome) to 100 (best functional outcome).	6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
Change in baseline Oxford Shoulder Score (OSS) after surgery	The OSS is a 12-item patient-reported outcome specifically designed and developed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. The score ranges from 0 (no pain or functional impairement) to 60 (worst pain and functional impairement).	6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
change in general health EQ5D score after surgery	EQ-5D is a standardized patient-reported outcome for measuring generic health status. The questionnaire has two components: a health state description measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. and a general evaluation of their overall health status using the visual analogue scale (EQ-VAS).	6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
change in baseline pain score using Visual Analogue Scales (VAS) after surgery	The VAS pain score is a patient-reported evaluation of pain intensity on a Visual Analogue Scales (VAS) between 0 (no pain) and 100 (worst pain imaginable).	6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
Translational deviation from planned implant position	translational deviation (in mm) of the implant position on post-operative shoulder CT scan when compared to the planned position on the pre-operative CT scan.	6 weeks after surgery
Rotational deviation from planned implant position	Rotational deviation (in degrees) of the implant position on post-operative shoulder CT scan when compared to the planned position on the pre-operative CT scan.	6 weeks after surgery
Translational deviation from initial implant position	translational deviation (in mm) on a shoulder CT scan 1 year after surgery, compared to the position on the post-operative CT scan.	1 year after surgery
Rotational deviation from initial implant position	Rotational deviation (in degrees) on a shoulder CT scan 1 year after surgery, compared to the position on the post-operative CT scan.	1 year after surgery
Scapular notching	scapular notching will be graded according to the Sirveaux classification system (2004) on a shoulder radiograph. The classification goes from 0 (no notching) to 4 (erosion over the inferior screw with extension under the baseplate)	6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
Radiolucensies	Radiolucencies surrounding the glenoid component will be graded according to the system of Lazarus (Lazarus et al 2002) on a shoulder radiograph. The classification goes from 0 (no lucensies) to 5 (gross lucensies and radiographic loosening)	6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
Heterotopic ossifications	periarticular heterotopic ossification (HO) will be scored according to a modified Brooker classification system of HO of the hip (Verhofste et al 2016) on a shoulder radiograph. The classification goes from 0 (no ossifications) to 3 (complete ankylosis of the shoulder)	6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
rate of implant revision surgeries up to 5 years after surgery	Implant survival will be calculated by calculating the rate of implant revision surgeries up to 5 years after surgery.	up to 5 years after surgery
Complication rate	the number and kind of (severe) adverse (device) events: device/shoulder related A(D)Es, SA(D)Es and device deficiencies that could have led to an SAE will be collected.	up to 5 year after surgery

Collaborators and Investigators

• Sponsor: Materialise

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: SMAT009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No