Hemiverse Shoulder Prosthesis

Pilot Study - Hemiverse Shoulder Prosthesis

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.

Study Overview

• Status: Recruiting
• Conditions: Hemiarthroplasty; Rotator Cuff Tears
• Intervention / Treatment: Other: Device: Hemiverse

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.

• Study Type: Interventional
• Enrollment (Estimated): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bernhard Jost, MD; Phone Number: +41 71 494 11 11; Email: Bernhard.Jost@kssg.ch

Study Locations

• Switzerland
  • Saint Gallen
    • St. Gallen, Saint Gallen, Switzerland, 9007
      • Recruiting
      • Kantonsspital St. Gallen, Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates
      • Contact: Bernhard Jost, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention/treatment; Implantation of the Hemiverse Shoulder Prothesis	Other: Device: Hemiverse; Implantation of the hemiverse shoulder prothesis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 41Hemiverse AG
• Collaborators: Cantonal Hospital of St. Gallen
• Investigators: Principal Investigator: Bernhard Jost, MD, Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Rupture; Wounds and Injuries; failure; salvage; total shoulder; Tendon Injuries; Shoulder Injuries; Rotator Cuff Injuries; hemiverse
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 41H01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No