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

• Conditions: Arthroplasty, Replacement, Shoulder; Glenoid Cavity; Osteoarthritis of the Shoulder
• Interventions: Device: reversed glenoid prothesis

• Registration Number: NCT03806881
• Lead Sponsor: Materialise

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

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 Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-16
• Study Start: 2019-07-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-10-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment group	reversed glenoid prothesis	Patients treated with a Glenius Glenoid Reconstruction System

Primary Outcome Measures

Name	Time	Method
Change in baseline Constant-Murley Score after surgery	6 weeks, 3 months, 1 year, 2 year, 5 years 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).

Secondary Outcome Measures

Name	Time	Method
Change in baseline Oxford Shoulder Score (OSS) after surgery	6 weeks, 3 months, 1 year, 2 year, 5 years 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).
Rotational deviation from initial implant position	1 year after surgery	Rotational deviation (in degrees) on a shoulder CT scan 1 year after surgery, compared to the position on the post-operative CT scan.
Scapular notching	6 weeks, 3 months, 1 year, 2 years, 5 years after surgery	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)
Radiolucensies	6 weeks, 3 months, 1 year, 2 years, 5 years after surgery	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)
Complication rate	up to 5 year after surgery	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.
Translational deviation from planned implant position	6 weeks after surgery	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.
rate of implant revision surgeries up to 5 years after surgery	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.
Change in baseline Simple Shoulder Test (SST) after surgery	6 weeks, 3 months, 1 year, 2 year, 5 years 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).
change in general health EQ5D score after surgery	6 weeks, 3 months, 1 year, 2 year, 5 years 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).
Rotational deviation from planned implant position	6 weeks after surgery	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.
change in baseline pain score using Visual Analogue Scales (VAS) after surgery	6 weeks, 3 months, 1 year, 2 year, 5 years 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).
Translational deviation from initial implant position	1 year after surgery	translational deviation (in mm) on a shoulder CT scan 1 year after surgery, compared to the position on the post-operative CT scan.
Heterotopic ossifications	6 weeks, 3 months, 1 year, 2 years, 5 years after surgery	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)

Trial Locations

Locations (4)

University Hospital Leuven - Traumatology; 🇧🇪 Leuven, Belgium

AZ St-Elisabeth; 🇧🇪 Herentals, Belgium

University Hospital Leuven - Orthopedics; 🇧🇪 Leuven, Belgium

Sint-Maartenskliniek; 🇳🇱 Nijmegen, Netherlands