Hemiverse Shoulder Prosthesis

Study Overview
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Brief Summary
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This clinical trial investigates the safety and the preliminary clinical benefit of the hemiverse shoulder prosthesis. Implantation of this newly developed hemi-prosthesis is intended for patients who do not qualify for a regular reverse or hemi-prosthesis due to severe medical conditions, poor bone stock or critical status of the rotator cuff. The expected benefit is, that patients will have a minimally invasive surgical procedure, only addressing the humeral shaft, however with the biomechanical advantage of a total reverse shoulder prosthesis, meaning, that with a minimally invasive surgery a comparable result as with a regular total shoulder prosthesis is accomplished. Patients will be closely monitored within the study protocol for 24 months and thereafter in regular interval as with a normal prosthetic follow-up.

Detailed Description
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This clinical trial investigates the safety and the preliminary clinical benefit of the hemiverse shoulder prosthesis. Implantation of this newly developed hemi-prosthesis is intended for patients who do not qualify for a regular reverse or hemi-prosthesis due to severe medical conditions, poor bone stock or critical status of the rotator cuff. To evaluate the clinical condition of the patient a clinical examination including evaluation of the Constant-Murley score, Subject shoulder value and visual analogue scale are performed before inclusion and during the regular follow-ups. To evaluate the bone stock and the musculature a conventional radiological status and a computed tomography of the shoulder will be performed. Surgical procedure: A delto-pectoral approach is preferred. The incision starts immediately lateral to the coracoid tip and extends to the insertion of the deltoid on the Humerus. The subscapularis tendon is exposed and detached from the humerus. The humeral head is exposed and dislocated from the joint using an oscillating saw the humeral head is resected. The shaft is prepared to receive a regular humeral stem which is definitely implanted with 0° retroversion. A trial implant is inserted and reduced into the joint. Free mobility of the joint is tested and the stability of the implant documented. According to the trial implants the definite implant is assembled and implanted. After reduction of the implant the subscapularis tendon is reattached to the humerus using transosseous sutures. Regular closure of the incision is performed. After-care: Immediately post operatively a anteroposterior radiograph is performed. For the first two post-operative weeks the arm is immobilised in a sling and external rotation is allowed until 0° and flexion until 90° in internal rotation. Thereafter gradual increase of active mobility is allowed until the weeks post operatively, when full load bearing of the arm is allowed. Regular follow-up visits include evaluation of the Constant-Murley score, Subject shoulder value and visual analogue scale. Additionally conventional radiographic status (anteroposterior lateral and axillary view) are performed post-operatively on day 1 or 2, week 6, 4.5 months, 6 months, 1 year and 2 years.

Official Title
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Pilot Study - Hemiverse Shoulder Prosthesis

Conditions
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Rotator Cuff Tears, Hemiarthroplasty

Intervention / Treatment
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* Other: Device: Hemiverse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥40 years Cuff failure with associated shoulder destruction which would be suited for hemiarthoplasty Shoulder joint destruction in which known alternatives would constitute either a high patient risk or a high functional failure risk. Shoulder destruction for which reverse total shoulder replacement would be a high risk for medical reasons (longer operation, more blood loss) or for advanced glenoid bone destruction Written informed consent Exclusion Criteria: Systemic contraindication according to internal medical and anesthesiological standards (e.g. Renal disease, Cardiopulmonary Disease, Heart Disease, Medication including Anticoagulation, Poorly controlled diabetes mellitus, Immunosuppressive drugs etc) Neuroarthropathy Moderate to severe motor axillary nerve dysfunction Moderate to severe destruction of deltoid muscle Fracture of the scapular spine or displaced fracture of the basis of the acromion Fracture of the base of the coracoid Destruction of more than superior one third of the humeral shaft Chronic inflammatory diseases,which the PI estimates contribute to a higher risk of surgery complications Inability to cooperate with postoperative regimen or to understand the trial information Impaired judgement

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention/treatment<br>Implantation of the Hemiverse Shoulder Prothesis | Other: Device: Hemiverse<br>* Implantation of the hemiverse shoulder prothesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event: Occurence of a fracture | Fracture of the humerus, the scapula and/or the clavicle (yes/no). | Assessments will take place after implantation at day 1 or 2 | 
| Adverse Event: Occurence of a fracture | Fracture of the humerus, the scapula and/or the clavicle (yes/no). | Assessments will take place after implantation at day 7 | 
| Adverse Event: Occurence of a fracture | Fracture of the humerus, the scapula and/or the clavicle (yes/no). | Assessments will take place after implantation at week 6 | 
| Adverse Event: Occurence of a fracture | Fracture of the humerus, the scapula and/or the clavicle (yes/no). | Assessments will take place after implantation at month 4.5 | 
| Adverse Event: Occurence of a fracture | Fracture of the humerus, the scapula and/or the clavicle (yes/no). | Assessments will take place after implantation at month 6 | 
| Adverse Event: Occurence of a fracture | Fracture of the humerus, the scapula and/or the clavicle (yes/no). | Assessments will take place after implantation at month 12 | 
| Adverse Event: Occurence of a fracture | Fracture of the humerus, the scapula and/or the clavicle (yes/no). | Assessments will take place after implantation at month 24 | 
| Adverse Event: Occurence of an infection | Infection at the implantation site (yes/no). | Assessments will take place after implantation at day 1 or 2 | 
| Adverse Event: Occurence of an infection | Infection at the implantation site (yes/no). | Assessments will take place after implantation at day 7 | 
| Adverse Event: Occurence of an infection | Infection at the implantation site (yes/no). | Assessments will take place after implantation at week 6 | 
| Adverse Event: Occurence of an infection | Infection at the implantation site (yes/no). | Assessments will take place after implantation at month 4.5 | 
| Adverse Event: Occurence of an infection | Infection at the implantation site (yes/no). | Assessments will take place after implantation at month 6 | 
| Adverse Event: Occurence of an infection | Infection at the implantation site (yes/no). | Assessments will take place after implantation at month 12 | 
| Adverse Event: Occurence of an infection | Infection at the implantation site (yes/no). | Assessments will take place after implantation at month 24 | 
| Adverse Event: Occurence of a hematoma | Presence of a hematoma at the implantation site (yes/no). | Assessments will take place after implantation at day 1 or 2 | 
| Adverse Event: Occurence of a hematoma | Presence of a hematoma at the implantation site (yes/no). | Assessments will take place after implantation at day 7 | 
| Adverse Event: Occurence of a hematoma | Presence of a hematoma at the implantation site (yes/no). | Assessments will take place after implantation at week 6 | 
| Adverse Event: Occurence of a hematoma | Presence of a hematoma at the implantation site (yes/no). | Assessments will take place after implantation at month 4.5 | 
| Adverse Event: Occurence of a hematoma | Presence of a hematoma at the implantation site (yes/no). | Assessments will take place after implantation at month 6 | 
| Adverse Event: Occurence of a hematoma | Presence of a hematoma at the implantation site (yes/no). | Assessments will take place after implantation at month 12 | 
| Adverse Event: Occurence of a hematoma | Presence of a hematoma at the implantation site (yes/no). | Assessments will take place after implantation at month 24 | 
| Adverse Event: Occurence of nerve damage | Nerve damage (yes/no). | Assessments will take place after implantation at day 1 or 2 | 
| Adverse Event: Occurence of nerve damage | Nerve damage (yes/no). | Assessments will take place after implantation at day 7 | 
| Adverse Event: Occurence of nerve damage | Nerve damage (yes/no). | Assessments will take place after implantation at week 6 | 
| Adverse Event: Occurence of nerve damage | Nerve damage (yes/no). | Assessments will take place after implantation at month 4.5 | 
| Adverse Event: Occurence of nerve damage | Nerve damage (yes/no). | Assessments will take place after implantation at month 6 | 
| Adverse Event: Occurence of nerve damage | Nerve damage (yes/no). | Assessments will take place after implantation at month 12 | 
| Adverse Event: Occurence of nerve damage | Nerve damage (yes/no). | Assessments will take place after implantation at month 24 | 
| Adverse Event: Occurence of implant dislocation | Dislocation of the implant (yes/no). | Assessments will take place after implantation at day 1 or 2 | 
| Adverse Event: Occurence of implant dislocation | Dislocation of the implant (yes/no). | Assessments will take place after implantation at day 7 | 
| Adverse Event: Occurence of implant dislocation | Dislocation of the implant (yes/no). | Assessments will take place after implantation at week 6 | 
| Adverse Event: Occurence of implant dislocation | Dislocation of the implant (yes/no). | Assessments will take place after implantation at month 4.5 | 
| Adverse Event: Occurence of implant dislocation | Dislocation of the implant (yes/no). | Assessments will take place after implantation at month 6 | 
| Adverse Event: Occurence of implant dislocation | Dislocation of the implant (yes/no). | Assessments will take place after implantation at month 12 | 
| Adverse Event: Occurence of implant dislocation | Dislocation of the implant (yes/no). | Assessments will take place after implantation at month 24 | 
| Adverse Event: Occurence of pulmonary embolism | Pulmonary embolism (yes/no). | Assessments will take place after implantation at day 1 or 2 | 
| Adverse Event: Occurence of pulmonary embolism | Pulmonary embolism (yes/no). | Assessments will take place after implantation at day 7 | 
| Adverse Event: Occurence of pulmonary embolism | Pulmonary embolism (yes/no). | Assessments will take place after implantation at week 6 | 
| Adverse Event: Occurence of pulmonary embolism | Pulmonary embolism (yes/no). | Assessments will take place after implantation at month 4.5 | 
| Adverse Event: Occurence of pulmonary embolism | Pulmonary embolism (yes/no). | Assessments will take place after implantation at month 6 | 
| Adverse Event: Occurence of pulmonary embolism | Pulmonary embolism (yes/no). | Assessments will take place after implantation at month 12 | 
| Adverse Event: Occurence of pulmonary embolism | Pulmonary embolism (yes/no). | Assessments will take place after implantation at month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain using a visual analogue scale: 0-100, 0=no pain 100=maximal imaginable pain | Highest pain level within last 25 hours will be recorded on a visual analogue scale | Assessment will take place at screening and the day before implantation and week 6, month 4.5, month 6, month 12 and month 24 | 
| Change of active range of motion | Active range of motion of the patient will be measured using a handheld goniometer for active elevation, abduction, external rotation and internal rotation | Assessment will take place at screening and the day before implantation and week 6, month 4.5, month 6, month 12 and month 24 | 
| Change of strength of abduction | isometric strength of abduction will be measured at 90 degrees scapular abduction using a validated device | Assessment will take place at screening and the day before implantation and week 6, month 4.5, month 6, month 12 and month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total shoulder, failure, salvage, Rotator Cuff Injuries, Rupture, Wounds and Injuries, Shoulder Injuries, Tendon Injuries, hemiverse