Pilot Study - Hemiverse Shoulder Prosthesis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tears
- Sponsor
- 41Hemiverse AG
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Adverse Event: Occurence of nerve damage
- Status
- Terminated
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Adverse Event: Occurence of nerve damage
Time Frame: Assessments will take place after implantation at month 24
Nerve damage (yes/no).
Adverse Event: Occurence of pulmonary embolism
Time Frame: Assessments will take place after implantation at month 24
Pulmonary embolism (yes/no).
Adverse Event: Occurence of a fracture
Time Frame: Assessments will take place after implantation at month 24
Fracture of the humerus, the scapula and/or the clavicle (yes/no).
Adverse Event: Occurence of an infection
Time Frame: Assessments will take place after implantation at month 24
Infection at the implantation site (yes/no).
Adverse Event: Occurence of a hematoma
Time Frame: Assessments will take place after implantation at month 24
Presence of a hematoma at the implantation site (yes/no).
Adverse Event: Occurence of implant dislocation
Time Frame: Assessments will take place after implantation at month 24
Dislocation of the implant (yes/no).
Secondary Outcomes
- 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 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)
- 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)