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

Osteoarthritis of the Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03806881
• Other study ID #: SMAT009
• Status: Enrolling by invitation
• Start date: July 1, 2019
• Est. completion date: December 1, 2028

Study information

• Verified date: March 2024
• Source: Materialise
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: December 1, 2028
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Belgium	AZ St-Elisabeth	Herentals
Belgium	University Hospital Leuven - Orthopedics	Leuven
Belgium	University Hospital Leuven - Traumatology	Leuven
Netherlands	Sint-Maartenskliniek	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Materialise

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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