Hemiverse Shoulder Prosthesis

Rotator Cuff Tears Clinical Trial

Official title:

Pilot Study - Hemiverse Shoulder Prosthesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04701268
• Other study ID #: 41H01
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: October 2023
• Source: 41Hemiverse AG
• Contact: Bernhard Jost, MD
• Phone: +41 71 494 11 11
• Email: Bernhard.Jost[@]kssg.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: June 30, 2026
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiarthroplasty
• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Other:
• Device: Hemiverse
Implantation of the hemiverse shoulder prothesis

Locations

Country	Name	City	State
Switzerland	Kantonsspital St. Gallen, Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates	St. Gallen	Saint Gallen

Sponsors (2)

Lead Sponsor	Collaborator
41Hemiverse AG	Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Adverse Event: Occurence of an infection	Infection at the implantation site (yes/no).	Assessments will take place after implantation at day 1 or 2
Primary	Adverse Event: Occurence of an infection	Infection at the implantation site (yes/no).	Assessments will take place after implantation at day 7
Primary	Adverse Event: Occurence of an infection	Infection at the implantation site (yes/no).	Assessments will take place after implantation at week 6
Primary	Adverse Event: Occurence of an infection	Infection at the implantation site (yes/no).	Assessments will take place after implantation at month 4.5
Primary	Adverse Event: Occurence of an infection	Infection at the implantation site (yes/no).	Assessments will take place after implantation at month 6
Primary	Adverse Event: Occurence of an infection	Infection at the implantation site (yes/no).	Assessments will take place after implantation at month 12
Primary	Adverse Event: Occurence of an infection	Infection at the implantation site (yes/no).	Assessments will take place after implantation at month 24
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Adverse Event: Occurence of nerve damage	Nerve damage (yes/no).	Assessments will take place after implantation at day 1 or 2
Primary	Adverse Event: Occurence of nerve damage	Nerve damage (yes/no).	Assessments will take place after implantation at day 7
Primary	Adverse Event: Occurence of nerve damage	Nerve damage (yes/no).	Assessments will take place after implantation at week 6
Primary	Adverse Event: Occurence of nerve damage	Nerve damage (yes/no).	Assessments will take place after implantation at month 4.5
Primary	Adverse Event: Occurence of nerve damage	Nerve damage (yes/no).	Assessments will take place after implantation at month 6
Primary	Adverse Event: Occurence of nerve damage	Nerve damage (yes/no).	Assessments will take place after implantation at month 12
Primary	Adverse Event: Occurence of nerve damage	Nerve damage (yes/no).	Assessments will take place after implantation at month 24
Primary	Adverse Event: Occurence of implant dislocation	Dislocation of the implant (yes/no).	Assessments will take place after implantation at day 1 or 2
Primary	Adverse Event: Occurence of implant dislocation	Dislocation of the implant (yes/no).	Assessments will take place after implantation at day 7
Primary	Adverse Event: Occurence of implant dislocation	Dislocation of the implant (yes/no).	Assessments will take place after implantation at week 6
Primary	Adverse Event: Occurence of implant dislocation	Dislocation of the implant (yes/no).	Assessments will take place after implantation at month 4.5
Primary	Adverse Event: Occurence of implant dislocation	Dislocation of the implant (yes/no).	Assessments will take place after implantation at month 6
Primary	Adverse Event: Occurence of implant dislocation	Dislocation of the implant (yes/no).	Assessments will take place after implantation at month 12
Primary	Adverse Event: Occurence of implant dislocation	Dislocation of the implant (yes/no).	Assessments will take place after implantation at month 24
Primary	Adverse Event: Occurence of pulmonary embolism	Pulmonary embolism (yes/no).	Assessments will take place after implantation at day 1 or 2
Primary	Adverse Event: Occurence of pulmonary embolism	Pulmonary embolism (yes/no).	Assessments will take place after implantation at day 7
Primary	Adverse Event: Occurence of pulmonary embolism	Pulmonary embolism (yes/no).	Assessments will take place after implantation at week 6
Primary	Adverse Event: Occurence of pulmonary embolism	Pulmonary embolism (yes/no).	Assessments will take place after implantation at month 4.5
Primary	Adverse Event: Occurence of pulmonary embolism	Pulmonary embolism (yes/no).	Assessments will take place after implantation at month 6
Primary	Adverse Event: Occurence of pulmonary embolism	Pulmonary embolism (yes/no).	Assessments will take place after implantation at month 12
Primary	Adverse Event: Occurence of pulmonary embolism	Pulmonary embolism (yes/no).	Assessments will take place after implantation at month 24
Secondary	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
Secondary	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
Secondary	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