Rotator Cuff TearHemiverseNCT03924063
Safety of the Hemiverse Shoulder Prothesis
A study testing Hemiverse in people with Rotator Cuff Tear and Hemiarthroplasty, run by Balgrist University Hospital at 1 site in Austria.
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 65 years and older
- Conditions the study is for
- Rotator Cuff Tear, Hemiarthroplasty
- What is being tested?
- Hemiverse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 14 May 2021to 14 May 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged ≥65 years
- Shoulder joint destruction in which known alternatives would constitute either a high patient risk or a high functional failure risk.
- Shoulder destruction suited for hemiarthroplasty except for present cuff failure
- 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
- Acute or chronic infection Clinical chemistry: C reactive protein <1.5 mg/dl), possible inclusion is under investigator decision.
- 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
- Destruction of more than superior one third of the humeral shaft
Show all 11Show fewer
- Hematology: hemoglobin (<10 and >16 g/dl), Hematocrit (<36 and >-48%), Anticoagulation
- Poorly controlled diabetes mellitus type I
- Immunosuppressive drugs
- 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 (dementia)
Trial locations and contacts
1 site in 1 country.
About this study
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 18 months and thereafter in regular interval was as with a normal prosthetic followup.
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 with thorough control of the blood parameters (hemoglobin, leucocytes, platelets, infection parameters) and including constant score and the quick dash score will be performed before the operation. 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 followup visits include a constant score, quick dash-score and conventional radiographic status(anteroposterior lateral and axillary view) and are performed to be post-operative 3 months 6 months 1 year and 18 months post operatively.
- Conditions
- Rotator Cuff Tear, Hemiarthroplasty
- Being tested
- Hemiverse
- Keywords
- total shoulder, failure, salvage
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemiverseDevice
Implantation of the hemiverse shoulderprothesis
| Study group | Role | What they receive |
|---|---|---|
| conservative treatment | Other | conservative treatment with physical therapy and non steroidal anti-inflammatory drugs Receives: Device: Hemiverse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of implantation of the Hemi verse shoulder prosthesis
Adverse Events like fracute, infection, hematoma, nerve demage will be summarized, all clinical data will be evaluated
Measured: Assessments will take place at day 7,
Safety of implantation of the Hemi verse shoulder prosthesis
Adverse Events like fracture, dislocation, infection, hematoma, pulmonary embolism, nerve demage will be summarized, all clinical data will be evaluated
Measured: Assessments will take place at 6 weeks
Safety of implantation of the Hemi verse shoulder prosthesis
Adverse events such as infection stiffness, dislocation, fracture requiring any modification of the expected course and treatment will bed reported at three months.
Measured: Assessments will take place at 3 months
Safety of implantation of the Hemi verse shoulder prosthesis
Adverse Events will be summarized, all clinical data will be evaluated
Measured: Assessments will take place at 6 months
Safety of implantation of the Hemi verse shoulder prosthesis
Adverse Events will be summarized, all clinical data will be evaluated
Measured: Assessments will take place at 12 months
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 at 6 weeks, 3 months, 6 months and 12 months
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 at 6 weeks, 3 months, 6 months and 12 months
change of strength of abduction
isometric strength of abduction will be measured at 90 degrees scapular abduction using a validated device starting at 3 months postoperatively until end of study
Measured: assessment at 6 weeks, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start14 May 2021
- Primary completion14 May 2021
- Study completion14 May 2021
Why it stopped: No suitable population available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Salzburger Landeskliniken
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924063
- Sponsor's protocol ID
- PMU27
- Acronym
- Hemiverse
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2019
- Last updated
- 15 Mar 2023
- 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 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of the Hemiverse Shoulder Prothesis
- ClinicalTrials.gov ID
- NCT03924063
- Acronym / sponsor ID
- Hemiverse / PMU27
- Conditions
- Rotator Cuff Tear, Hemiarthroplasty
- Keywords
- total shoulder, failure, salvage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No suitable population available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Salzburger Landeskliniken
- Study start
- 14 May 2021 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 23 Apr 2019 (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 18 months and thereafter in regular interval was as with a normal prosthetic followup.
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 with thorough control of the blood parameters (hemoglobin, leucocytes, platelets, infection parameters) and including constant score and the quick dash score will be performed before the operation. 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 followup visits include a constant score, quick dash-score and conventional radiographic status(anteroposterior lateral and axillary view) and are performed to be post-operative 3 months 6 months 1 year and 18 months post operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| conservative treatment | Other | Device: Hemiverseconservative treatment with physical therapy and non steroidal anti-inflammatory drugs |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥65 years
- Shoulder joint destruction in which known alternatives would constitute either a high patient risk or a high functional failure risk.
- Shoulder destruction suited for hemiarthroplasty except for present cuff failure
- 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 (11 listed)
- Acute or chronic infection Clinical chemistry: C reactive protein <1.5 mg/dl), possible inclusion is under investigator decision.
- 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 |
|---|---|---|
| HemiverseImplantation of the hemiverse shoulderprothesis | Device | conservative treatment |
Primary outcome
Safety of implantation of the Hemi verse shoulder prosthesis
Time frame: Assessments will take place at day 7,
Adverse Events like fracute, infection, hematoma, nerve demage will be summarized, all clinical data will be evaluated
Safety of implantation of the Hemi verse shoulder prosthesis
Time frame: Assessments will take place at 6 weeks
Adverse Events like fracture, dislocation, infection, hematoma, pulmonary embolism, nerve demage will be summarized, all clinical data will be evaluated
Safety of implantation of the Hemi verse shoulder prosthesis
Time frame: Assessments will take place at 3 months
Adverse events such as infection stiffness, dislocation, fracture requiring any modification of the expected course and treatment will bed reported at three months.
Safety of implantation of the Hemi verse shoulder prosthesis
Time frame: Assessments will take place at 6 months
Adverse Events will be summarized, all clinical data will be evaluated
Safety of implantation of the Hemi verse shoulder prosthesis
Time frame: Assessments will take place at 12 months
Adverse Events will be summarized, all clinical data will be evaluated
3 secondary outcomes
change of pain using a visual analogue scale: 0-100, 0=no pain 100=maximal imaginable pain
Time frame: assessment at 6 weeks, 3 months, 6 months and 12 months
change of active range of motion
Time frame: assessment at 6 weeks, 3 months, 6 months and 12 months
change of strength of abduction
Time frame: assessment at 6 weeks, 3 months, 6 months and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemiverse in people with Rotator Cuff Tear and Hemiarthroplasty, run by Balgrist University Hospital at 1 site in Austria.
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 11 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: withdrawn, as of the sponsor's last update on 15 Mar 2023. 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 Austria. 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 withdrawn before enrolling participants, so there are no results.
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?
Safety of implantation of the Hemi verse shoulder prosthesis (time frame: Assessments will take place at day 7,). The study lists 5 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 15 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.