Hemiverse Shoulder Prosthesis

NCT ID: NCT04701268

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2024-06-24

Brief Summary

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

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.

Conditions

Rotator Cuff Tears; Hemiarthroplasty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention/treatment

Implantation of the Hemiverse Shoulder Prothesis

Group Type: EXPERIMENTAL

Device: Hemiverse

Intervention Type: OTHER

Implantation of the hemiverse shoulder prothesis

Interventions

Device: Hemiverse

Implantation of the hemiverse shoulder prothesis

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: collaborator

41Hemiverse AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernhard Jost, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates

Locations

Kantonsspital St. Gallen, Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates

Sankt Gallen, Canton of St. Gallen, Switzerland

Countries

Switzerland

Other Identifiers

41H01

Identifier Type: -

Identifier Source: org_study_id