NCT04701268

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
Last Updated

August 27, 2024

Status Verified

October 1, 2023

Enrollment Period

2.9 years

First QC Date

December 15, 2020

Last Update Submit

August 26, 2024

Conditions

Rotator Cuff TearsHemiarthroplasty

Keywords

total shoulderfailuresalvageRotator Cuff InjuriesRuptureWounds and InjuriesShoulder InjuriesTendon Injurieshemiverse

Outcome Measures

Primary Outcomes (42)

  • 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 Outcomes (3)

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

    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

    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

    Assessment will take place at screening and the day before implantation and week 6, month 4.5, month 6, month 12 and month 24

Study Arms (1)

Intervention/treatment

EXPERIMENTAL

Implantation of the Hemiverse Shoulder Prothesis

Other: Device: Hemiverse

Interventions

Device: HemiverseOTHER

Implantation of the hemiverse shoulder prothesis

Intervention/treatment

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesRuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Bernhard Jost, MD

    Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 15, 2020

First Posted

January 8, 2021

Study Start

July 15, 2021

Primary Completion

June 24, 2024

Study Completion

June 24, 2024

Last Updated

August 27, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)