Safety of the Hemiverse Shoulder Prothesis

NCT03924063 | Withdrawn DMC

• 1 other identifier: PMU27
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear; Hemiarthroplasty

Keywords

total shoulder; failure; salvage

Outcome Measures

Primary Outcomes (5)

• Safety of implantation of the Hemi verse shoulder prosthesis

  Adverse Events like fracute, infection, hematoma, nerve demage will be summarized, all clinical data will be evaluated

  Assessments will take place at day 7,

• Safety of implantation of the Hemi verse shoulder prosthesis

  Adverse Events like fracture, dislocation, infection, hematoma, pulmonary embolism, nerve demage will be summarized, all clinical data will be evaluated

  Assessments will take place at 6 weeks

• Safety of implantation of the Hemi verse shoulder prosthesis

  Adverse events such as infection stiffness, dislocation, fracture requiring any modification of the expected course and treatment will bed reported at three months.

  Assessments will take place at 3 months

• Safety of implantation of the Hemi verse shoulder prosthesis

  Adverse Events will be summarized, all clinical data will be evaluated

  Assessments will take place at 6 months

• Safety of implantation of the Hemi verse shoulder prosthesis

  Adverse Events will be summarized, all clinical data will be evaluated

  Assessments will take place at 12 months

Secondary Outcomes (3)

• change of pain using a visual analogue scale: 0-100, 0=no pain 100=maximal imaginable pain

  assessment at 6 weeks, 3 months, 6 months and 12 months

• change of active range of motion

  assessment at 6 weeks, 3 months, 6 months and 12 months

• change of strength of abduction

  assessment at 6 weeks, 3 months, 6 months and 12 months

Study Arms (1)

conservative treatment

OTHER

conservative treatment with physical therapy and non steroidal anti-inflammatory drugs

Device: Hemiverse

Interventions

Hemiverse DEVICE

Implantation of the hemiverse shoulderprothesis

conservative treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Balgrist University Hospital: lead
• Salzburger Landeskliniken: collaborator

Study Sites (1)

Landkrankenhaus Salzburg

Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 23, 2019
• Study Start: May 14, 2021
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)