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Rotator Cuff Tears
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Pilot Study - Hemiverse Shoulder Prosthesis

Sponsored by 41Hemiverse AG

About this trial

Last updated 3 years ago

Study ID

41H01

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
40+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting