Safety of the Hemiverse Shoulder Prothesis (Hemiverse)

• ClinicalTrials.gov Identifier: NCT03924063
• Recruitment Status: Terminated
• First Posted: April 23, 2019
• Last Update Posted: May 18, 2021
• Sponsor: Balgrist University Hospital
• Collaborator: Salzburger Landeskliniken
• Information provided by (Responsible Party): Balgrist University Hospital

Study Description

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 18 months and thereafter in regular interval was as with a normal prosthetic followup.

Condition or disease	Intervention/treatment	Phase
Rotator Cuff Tear; Hemiarthroplasty	Device: Hemiverse	Not Applicable

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 with thorough control of the blood parameters (hemoglobin, leucocytes, platelets, infection parameters) and including constant score and the quick dash score will be performed before the operation. 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 followup visits include a constant score, quick dash-score and conventional radiographic status(anteroposterior lateral and axillary view) and are performed to be post-operative 3 months 6 months 1 year and 18 months post operatively.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety of the Hemiverse Shoulder Prothesis
• Actual Study Start Date: May 14, 2021
• Actual Primary Completion Date: May 14, 2021
• Actual Study Completion Date: May 14, 2021

Arms and Interventions

Arm	Intervention/treatment
conservative treatment; conservative treatment with physical therapy and non steroidal anti-inflammatory drugs	Device: Hemiverse; Implantation of the hemiverse shoulderprothesis

Outcome Measures

Primary Outcome Measures :

1. Safety of implantation of the Hemi verse shoulder prosthesis [ Time Frame: Assessments will take place at day 7, ]
   Adverse Events like fracute, infection, hematoma, nerve demage will be summarized, all clinical data will be evaluated
2. Safety of implantation of the Hemi verse shoulder prosthesis [ Time Frame: Assessments will take place at 6 weeks ]
   Adverse Events like fracture, dislocation, infection, hematoma, pulmonary embolism, nerve demage will be summarized, all clinical data will be evaluated
3. Safety of implantation of the Hemi verse shoulder prosthesis [ Time Frame: Assessments will take place at 3 months ]
   Adverse events such as infection stiffness, dislocation, fracture requiring any modification of the expected course and treatment will bed reported at three months.
4. Safety of implantation of the Hemi verse shoulder prosthesis [ Time Frame: Assessments will take place at 6 months ]
   Adverse Events will be summarized, all clinical data will be evaluated
5. Safety of implantation of the Hemi verse shoulder prosthesis [ Time Frame: Assessments will take place at 12 months ]
   Adverse Events will be summarized, all clinical data will be evaluated

Secondary Outcome Measures :

1. change of pain using a visual analogue scale: 0-100, 0=no pain 100=maximal imaginable pain [ Time Frame: assessment at 6 weeks, 3 months, 6 months and 12 months ]
   highest pain level within last 25 hours will be recorded on a visual analogue scale
2. change of active range of motion [ Time Frame: assessment at 6 weeks, 3 months, 6 months and 12 months ]
   active range of motion of the patient will be measured using a handheld goniometer for active elevation, abduction, external rotation and internal rotation
3. change of strength of abduction [ Time Frame: assessment at 6 weeks, 3 months, 6 months and 12 months ]
   isometric strength of abduction will be measured at 90 degrees scapular abduction using a validated device starting at 3 months postoperatively until end of study

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients aged ≥65 years
• Shoulder joint destruction in which known alternatives would constitute either a high patient risk or a high functional failure risk.
• Shoulder destruction suited for hemiarthroplasty except for present cuff failure
• 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:

• Acute or chronic infection Clinical chemistry: C reactive protein <1.5 mg/dl), possible inclusion is under investigator decision.
• 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
• Destruction of more than superior one third of the humeral shaft
• Hematology: hemoglobin (<10 and >16 g/dl), Hematocrit (<36 and >-48%), Anticoagulation
• Poorly controlled diabetes mellitus type I
• Immunosuppressive drugs
• 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 (dementia)

Contacts and Locations

Locations

Austria

Landkrankenhaus Salzburg

Salzburg, Austria, 5020

Sponsors and Collaborators

Balgrist University Hospital

Salzburger Landeskliniken

More Information

• Responsible Party: Balgrist University Hospital
• ClinicalTrials.gov Identifier: NCT03924063
• Other Study ID Numbers: PMU27
• First Posted: April 23, 2019
• Last Update Posted: May 18, 2021
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Balgrist University Hospital:

total shoulder; failure; salvage

Additional relevant MeSH terms:

Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries