Rotator Cuff TearsNCT04701268
Hemiverse Shoulder Prosthesis
A study testing Device: Hemiverse in people with Rotator Cuff Tears and Hemiarthroplasty, run by 41Hemiverse AG at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Rotator Cuff Tears, Hemiarthroplasty
- What is being tested?
- Device: Hemiverse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jul 2021to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital St. Gallen, Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates
Sankt Gallen, Canton of St. Gallen, 9007
About this study
Official title: Pilot Study - Hemiverse Shoulder Prosthesis
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.
Read the 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.
- Conditions
- Rotator Cuff Tears, Hemiarthroplasty
- Being tested
- Device: Hemiverse
- Keywords
- total shoulder, failure, salvage, Rotator Cuff Injuries, Rupture, Wounds and Injuries, Shoulder Injuries, Tendon Injuries, hemiverse
- Medical subject headings
- Rotator Cuff Injuries, Rupture, Wounds and Injuries, Shoulder Injuries, Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: HemiverseOther
Implantation of the hemiverse shoulder prothesis
| Study group | Role | What they receive |
|---|---|---|
| Intervention/treatment | Experimental | Implantation of the Hemiverse Shoulder Prothesis Receives: Other: Device: Hemiverse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event: Occurence of a fracture
Fracture of the humerus, the scapula and/or the clavicle (yes/no).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Assessments will take place after implantation at month 24
Adverse Event: Occurence of an infection
Infection at the implantation site (yes/no).
Measured: Assessments will take place after implantation at day 1 or 2
Adverse Event: Occurence of an infection
Infection at the implantation site (yes/no).
Measured: Assessments will take place after implantation at day 7
Adverse Event: Occurence of an infection
Infection at the implantation site (yes/no).
Measured: Assessments will take place after implantation at week 6
Adverse Event: Occurence of an infection
Infection at the implantation site (yes/no).
Measured: Assessments will take place after implantation at month 4.5
Adverse Event: Occurence of an infection
Infection at the implantation site (yes/no).
Measured: Assessments will take place after implantation at month 6
Adverse Event: Occurence of an infection
Infection at the implantation site (yes/no).
Measured: Assessments will take place after implantation at month 12
Adverse Event: Occurence of an infection
Infection at the implantation site (yes/no).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Assessments will take place after implantation at month 24
Adverse Event: Occurence of nerve damage
Nerve damage (yes/no).
Measured: Assessments will take place after implantation at day 1 or 2
Adverse Event: Occurence of nerve damage
Nerve damage (yes/no).
Measured: Assessments will take place after implantation at day 7
Adverse Event: Occurence of nerve damage
Nerve damage (yes/no).
Measured: Assessments will take place after implantation at week 6
Adverse Event: Occurence of nerve damage
Nerve damage (yes/no).
Measured: Assessments will take place after implantation at month 4.5
Adverse Event: Occurence of nerve damage
Nerve damage (yes/no).
Measured: Assessments will take place after implantation at month 6
Adverse Event: Occurence of nerve damage
Nerve damage (yes/no).
Measured: Assessments will take place after implantation at month 12
Adverse Event: Occurence of nerve damage
Nerve damage (yes/no).
Measured: Assessments will take place after implantation at month 24
Adverse Event: Occurence of implant dislocation
Dislocation of the implant (yes/no).
Measured: Assessments will take place after implantation at day 1 or 2
Adverse Event: Occurence of implant dislocation
Dislocation of the implant (yes/no).
Measured: Assessments will take place after implantation at day 7
Adverse Event: Occurence of implant dislocation
Dislocation of the implant (yes/no).
Measured: Assessments will take place after implantation at week 6
Adverse Event: Occurence of implant dislocation
Dislocation of the implant (yes/no).
Measured: Assessments will take place after implantation at month 4.5
Adverse Event: Occurence of implant dislocation
Dislocation of the implant (yes/no).
Measured: Assessments will take place after implantation at month 6
Adverse Event: Occurence of implant dislocation
Dislocation of the implant (yes/no).
Measured: Assessments will take place after implantation at month 12
Adverse Event: Occurence of implant dislocation
Dislocation of the implant (yes/no).
Measured: Assessments will take place after implantation at month 24
Adverse Event: Occurence of pulmonary embolism
Pulmonary embolism (yes/no).
Measured: Assessments will take place after implantation at day 1 or 2
Adverse Event: Occurence of pulmonary embolism
Pulmonary embolism (yes/no).
Measured: Assessments will take place after implantation at day 7
Adverse Event: Occurence of pulmonary embolism
Pulmonary embolism (yes/no).
Measured: Assessments will take place after implantation at week 6
Adverse Event: Occurence of pulmonary embolism
Pulmonary embolism (yes/no).
Measured: Assessments will take place after implantation at month 4.5
Adverse Event: Occurence of pulmonary embolism
Pulmonary embolism (yes/no).
Measured: Assessments will take place after implantation at month 6
Adverse Event: Occurence of pulmonary embolism
Pulmonary embolism (yes/no).
Measured: Assessments will take place after implantation at month 12
Adverse Event: Occurence of pulmonary embolism
Pulmonary embolism (yes/no).
Measured: 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
Highest pain level within last 25 hours will be recorded on a visual analogue scale
Measured: 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
Active range of motion of the patient will be measured using a handheld goniometer for active elevation, abduction, external rotation and internal rotation
Measured: 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
isometric strength of abduction will be measured at 90 degrees scapular abduction using a validated device
Measured: Assessment will take place at screening and the day before implantation and week 6, month 4.5, month 6, month 12 and month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start15 Jul 2021
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Why it stopped: Decision Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- 41Hemiverse AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cantonal Hospital of St. Gallen
- Responsible party
- Sponsor
- Investigators
- Bernhard Jost, MD, Principal investigator, Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701268
- Sponsor's protocol ID
- 41H01
- Status last verified
- Oct 2023
- First submitted
- 15 Dec 2020
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study - Hemiverse Shoulder Prosthesis
- ClinicalTrials.gov ID
- NCT04701268
- Acronym / sponsor ID
- 41H01
- Conditions
- Rotator Cuff Tears, Hemiarthroplasty
- Keywords
- total shoulder, failure, salvage, Rotator Cuff Injuries, Rupture, Wounds and Injuries, Shoulder Injuries, Tendon Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision Sponsor
- Enrolment
- 2 participants (actual)
- Lead sponsor
- 41Hemiverse AGIndustry (pharma, biotech, devices)
- Collaborators
- Cantonal Hospital of St. Gallen
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention/treatment | Experimental | Other: Device: HemiverseImplantation of the Hemiverse Shoulder Prothesis |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: HemiverseImplantation of the hemiverse shoulder prothesis | Other | Intervention/treatment |
Primary outcome
Adverse Event: Occurence of a fracture
Time frame: Assessments will take place after implantation at day 1 or 2
Fracture of the humerus, the scapula and/or the clavicle (yes/no).
Adverse Event: Occurence of a fracture
Time frame: Assessments will take place after implantation at day 7
Fracture of the humerus, the scapula and/or the clavicle (yes/no).
Adverse Event: Occurence of a fracture
Time frame: Assessments will take place after implantation at week 6
Fracture of the humerus, the scapula and/or the clavicle (yes/no).
Adverse Event: Occurence of a fracture
Time frame: Assessments will take place after implantation at month 4.5
Fracture of the humerus, the scapula and/or the clavicle (yes/no).
Adverse Event: Occurence of a fracture
Time frame: Assessments will take place after implantation at month 6
Fracture of the humerus, the scapula and/or the clavicle (yes/no).
Adverse Event: Occurence of a fracture
Time frame: Assessments will take place after implantation at month 12
Fracture of the humerus, the scapula and/or the clavicle (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 day 1 or 2
Infection at the implantation site (yes/no).
Adverse Event: Occurence of an infection
Time frame: Assessments will take place after implantation at day 7
Infection at the implantation site (yes/no).
Adverse Event: Occurence of an infection
Time frame: Assessments will take place after implantation at week 6
Infection at the implantation site (yes/no).
Adverse Event: Occurence of an infection
Time frame: Assessments will take place after implantation at month 4.5
Infection at the implantation site (yes/no).
Adverse Event: Occurence of an infection
Time frame: Assessments will take place after implantation at month 6
Infection at the implantation site (yes/no).
Adverse Event: Occurence of an infection
Time frame: Assessments will take place after implantation at month 12
Infection at the implantation site (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 day 1 or 2
Presence of a hematoma at the implantation site (yes/no).
Adverse Event: Occurence of a hematoma
Time frame: Assessments will take place after implantation at day 7
Presence of a hematoma at the implantation site (yes/no).
Adverse Event: Occurence of a hematoma
Time frame: Assessments will take place after implantation at week 6
Presence of a hematoma at the implantation site (yes/no).
Adverse Event: Occurence of a hematoma
Time frame: Assessments will take place after implantation at month 4.5
Presence of a hematoma at the implantation site (yes/no).
Adverse Event: Occurence of a hematoma
Time frame: Assessments will take place after implantation at month 6
Presence of a hematoma at the implantation site (yes/no).
Adverse Event: Occurence of a hematoma
Time frame: Assessments will take place after implantation at month 12
Presence of a hematoma 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 nerve damage
Time frame: Assessments will take place after implantation at day 1 or 2
Nerve damage (yes/no).
Adverse Event: Occurence of nerve damage
Time frame: Assessments will take place after implantation at day 7
Nerve damage (yes/no).
Adverse Event: Occurence of nerve damage
Time frame: Assessments will take place after implantation at week 6
Nerve damage (yes/no).
Adverse Event: Occurence of nerve damage
Time frame: Assessments will take place after implantation at month 4.5
Nerve damage (yes/no).
Adverse Event: Occurence of nerve damage
Time frame: Assessments will take place after implantation at month 6
Nerve damage (yes/no).
Adverse Event: Occurence of nerve damage
Time frame: Assessments will take place after implantation at month 12
Nerve damage (yes/no).
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 implant dislocation
Time frame: Assessments will take place after implantation at day 1 or 2
Dislocation of the implant (yes/no).
Adverse Event: Occurence of implant dislocation
Time frame: Assessments will take place after implantation at day 7
Dislocation of the implant (yes/no).
Adverse Event: Occurence of implant dislocation
Time frame: Assessments will take place after implantation at week 6
Dislocation of the implant (yes/no).
Adverse Event: Occurence of implant dislocation
Time frame: Assessments will take place after implantation at month 4.5
Dislocation of the implant (yes/no).
Adverse Event: Occurence of implant dislocation
Time frame: Assessments will take place after implantation at month 6
Dislocation of the implant (yes/no).
Adverse Event: Occurence of implant dislocation
Time frame: Assessments will take place after implantation at month 12
Dislocation of the implant (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).
Adverse Event: Occurence of pulmonary embolism
Time frame: Assessments will take place after implantation at day 1 or 2
Pulmonary embolism (yes/no).
Adverse Event: Occurence of pulmonary embolism
Time frame: Assessments will take place after implantation at day 7
Pulmonary embolism (yes/no).
Adverse Event: Occurence of pulmonary embolism
Time frame: Assessments will take place after implantation at week 6
Pulmonary embolism (yes/no).
Adverse Event: Occurence of pulmonary embolism
Time frame: Assessments will take place after implantation at month 4.5
Pulmonary embolism (yes/no).
Adverse Event: Occurence of pulmonary embolism
Time frame: Assessments will take place after implantation at month 6
Pulmonary embolism (yes/no).
Adverse Event: Occurence of pulmonary embolism
Time frame: Assessments will take place after implantation at month 12
Pulmonary embolism (yes/no).
Adverse Event: Occurence of pulmonary embolism
Time frame: Assessments will take place after implantation at month 24
Pulmonary embolism (yes/no).
3 secondary outcomes
Change of pain using a visual analogue scale: 0-100, 0=no pain 100=maximal imaginable pain
Time frame: 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
Time frame: 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
Time frame: Assessment will take place at screening and the day before implantation and week 6, month 4.5, month 6, month 12 and month 24
Results and safety
The study was stopped early (reason given: Decision Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Jost, MD principal investigator
Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Hemiverse in people with Rotator Cuff Tears and Hemiarthroplasty, run by 41Hemiverse AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Decision Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event: Occurence of a fracture (time frame: Assessments will take place after implantation at day 1 or 2). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.