Clinical trial NCT04701268: Hemiverse Shoulder Prosthesis
Official title: Pilot Study - Hemiverse Shoulder Prosthesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rotator Cuff Tears
Hemiarthroplasty
Keywords: total shoulder
failure
salvage
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
hemiverse
Lead sponsor: 41Hemiverse AG
Sponsor class: INDUSTRY
Collaborators: name: Cantonal Hospital of St. Gallen
First posted: 2021-01-08
Enrollment: 2
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adverse Event: Occurence of a fracture
timeFrame: Assessments will take place after implantation at day 1 or 2
measure: Adverse Event: Occurence of a fracture
timeFrame: Assessments will take place after implantation at day 7
measure: Adverse Event: Occurence of a fracture
timeFrame: Assessments will take place after implantation at week 6
measure: Adverse Event: Occurence of a fracture
timeFrame: Assessments will take place after implantation at month 4.5
measure: Adverse Event: Occurence of a fracture
timeFrame: Assessments will take place after implantation at month 6
measure: Adverse Event: Occurence of a fracture
timeFrame: Assessments will take place after implantation at month 12
measure: Adverse Event: Occurence of a fracture
timeFrame: Assessments will take place after implantation at month 24
measure: Adverse Event: Occurence of an infection
timeFrame: Assessments will take place after implantation at day 1 or 2
measure: Adverse Event: Occurence of an infection
timeFrame: Assessments will take place after implantation at day 7
measure: Adverse Event: Occurence of an infection
timeFrame: Assessments will take place after implantation at week 6
measure: Adverse Event: Occurence of an infection
timeFrame: Assessments will take place after implantation at month 4.5
measure: Adverse Event: Occurence of an infection
timeFrame: Assessments will take place after implantation at month 6
measure: Adverse Event: Occurence of an infection
timeFrame: Assessments will take place after implantation at month 12
measure: Adverse Event: Occurence of an infection
timeFrame: Assessments will take place after implantation at month 24
measure: Adverse Event: Occurence of a hematoma
timeFrame: Assessments will take place after implantation at day 1 or 2
measure: Adverse Event: Occurence of a hematoma
timeFrame: Assessments will take place after implantation at day 7
measure: Adverse Event: Occurence of a hematoma
timeFrame: Assessments will take place after implantation at week 6
measure: Adverse Event: Occurence of a hematoma
timeFrame: Assessments will take place after implantation at month 4.5
measure: Adverse Event: Occurence of a hematoma
timeFrame: Assessments will take place after implantation at month 6
measure: Adverse Event: Occurence of a hematoma
timeFrame: Assessments will take place after implantation at month 12
measure: Adverse Event: Occurence of a hematoma
timeFrame: Assessments will take place after implantation at month 24
measure: Adverse Event: Occurence of nerve damage
timeFrame: Assessments will take place after implantation at day 1 or 2
measure: Adverse Event: Occurence of nerve damage
timeFrame: Assessments will take place after implantation at day 7
measure: Adverse Event: Occurence of nerve damage
timeFrame: Assessments will take place after implantation at week 6
measure: Adverse Event: Occurence of nerve damage
timeFrame: Assessments will take place after implantation at month 4.5
measure: Adverse Event: Occurence of nerve damage
timeFrame: Assessments will take place after implantation at month 6
measure: Adverse Event: Occurence of nerve damage
timeFrame: Assessments will take place after implantation at month 12
measure: Adverse Event: Occurence of nerve damage
timeFrame: Assessments will take place after implantation at month 24
measure: Adverse Event: Occurence of implant dislocation
timeFrame: Assessments will take place after implantation at day 1 or 2
measure: Adverse Event: Occurence of implant dislocation
timeFrame: Assessments will take place after implantation at day 7
measure: Adverse Event: Occurence of implant dislocation
timeFrame: Assessments will take place after implantation at week 6
measure: Adverse Event: Occurence of implant dislocation
timeFrame: Assessments will take place after implantation at month 4.5
measure: Adverse Event: Occurence of implant dislocation
timeFrame: Assessments will take place after implantation at month 6
measure: Adverse Event: Occurence of implant dislocation
timeFrame: Assessments will take place after implantation at month 12
measure: Adverse Event: Occurence of implant dislocation
timeFrame: Assessments will take place after implantation at month 24
measure: Adverse Event: Occurence of pulmonary embolism
timeFrame: Assessments will take place after implantation at day 1 or 2
measure: Adverse Event: Occurence of pulmonary embolism
timeFrame: Assessments will take place after implantation at day 7
measure: Adverse Event: Occurence of pulmonary embolism
timeFrame: Assessments will take place after implantation at week 6
measure: Adverse Event: Occurence of pulmonary embolism
timeFrame: Assessments will take place after implantation at month 4.5
measure: Adverse Event: Occurence of pulmonary embolism
timeFrame: Assessments will take place after implantation at month 6
measure: Adverse Event: Occurence of pulmonary embolism
timeFrame: Assessments will take place after implantation at month 12
measure: Adverse Event: Occurence of pulmonary embolism
timeFrame: Assessments will take place after implantation at month 24
Secondary outcomes:
measure: Change of pain using a visual analogue scale: 0-100, 0=no pain 100=maximal imaginable pain
timeFrame: Assessment will take place at screening and the day before implantation and week 6, month 4.5, month 6, month 12 and month 24
measure: Change of active range of motion
timeFrame: Assessment will take place at screening and the day before implantation and week 6, month 4.5, month 6, month 12 and month 24
measure: Change of strength of abduction
timeFrame: Assessment will take place at screening and the day before implantation and week 6, month 4.5, month 6, month 12 and month 24
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen, Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates
state: Saint Gallen
Study officials:
affiliation: Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates
name: Bernhard Jost, MD
role: PRINCIPAL_INVESTIGATOR
References: