Shoulder FracturesNCT04507880
A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
A study testing Reverse Total Shoulder Arthroplasty and Hemiarthroplasty in people with Shoulder Fractures, run by Signe Rosner Rasmussen.
Trial summary
The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder. Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Shoulder Fractures
- What is being tested?
- Reverse Total Shoulder Arthroplasty and Hemiarthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 1 Aug 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 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Fracture or fracture dislocation not suitable for non-operative treatment or for osteosynthesis due to displacement and comminution
- Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older.
- All patients, regardless of age, with an insufficient or irreparable rotator cuff
Who cannot join
- Brachial plexus palsy
- Previous ipsilateral fracture of clavicula, scapula, or proximal humerus
- Cognitive disabilities or substance abuse enabling rehabilitation and follow-up
- Patients without a Danish civil registration number
Trial locations and contacts
No sites are listed yet.
About this study
The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder.
- Conditions
- Shoulder Fractures
- Being tested
- Reverse Total Shoulder Arthroplasty, Hemiarthroplasty
- Keywords
- Humeral Fractures, Proximal
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Total Shoulder ArthroplastyDevice
The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.
HemiarthroplastyDevice
The shoulder hemiarthroplasty
| Study group | Role | What they receive |
|---|---|---|
| RTSA group | Experimental | Participants with a complex proximal humerus fracture given a RTSA Receives: Device: Reverse Total Shoulder Arthroplasty |
| Hemiarthroplasty group | Active comparator | Historical cohort of participants, operated with a hemiarthroplasty of the shoulder Receives: Device: Hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Constant score (CS)
The CS consists of four parameters (pain, mobility, ADL, strength) assessing shoulder function after the treatment of shoulder injury, both subjectively and objectively. The scale rates from worst (0) to best (100) quality of shoulder function.
Measured: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Secondary outcomes (6)
Change in Oxford Shoulder Score (OSS)
The OSS is a patient related outcome-measure (PROM) validated for evaluating self-assessed functionality after shoulder surgery. The 12 questions, with five response options, gives a total score ranging from 12 points (no pain or functional impairment) to 60 points (worst).
Measured: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
The WOOS is a patient-related outcome measurement, initially validated for patients with osteoarthritis of the shoulder. On four domains (physical symptoms, recreation/work, lifestyle, emotions) the visual analog scale measures shoulder-related quality-of-life with a maximum of 1900 points, which signifies highest quality of function.
Measured: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Change in EQ5D questionnaire
The EQ-5D (EuroQuol 5 Dimension scale) questionnaire is a widely used patient-related outcome measurement for quality of life assessment in general, consisting of 25 dichotomous questions from five parameters and a visual analog scale to plot perceived health. A persons selfperceived health status is then evaluated as a 5-digit number, ranging from 11111 (having no problems) to 33333 (having problems in all 5 aspects), and as a number from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Change in Numeric Ranking Scale
Pain measured after surgery according to the Numeric Ranking Scale (NRS), where 0 is no pain and 10 is worst imaginable pain.
Measured: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Complications
Postoperative complications or reoperation due to infection, nerve damage, vascular damage, iatrogenic perioperative fracture, or loosening of the implant.
Measured: The outcome is registered 2 years after surgery
Change in humeral tuberosities
Migration or resorption of the humeral tuberosities accessed qualitatively from the xrays.
Measured: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder FracturesStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Signe Rosner Rasmussen
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Responsible party
- Sponsor-investigator, Signe Rosner Rasmussen, Herlev and Gentofte Hospital
- Investigators
- Bo S Olsen, Professor, Study chair, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507880
- Sponsor's protocol ID
- 71005
- Status last verified
- Jul 2020
- First submitted
- 31 Jul 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
- ClinicalTrials.gov ID
- NCT04507880
- Acronym / sponsor ID
- 71005
- Conditions
- Shoulder Fractures
- Keywords
- Humeral Fractures, Proximal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Signe Rosner RasmussenUniversity, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 11 Aug 2020 (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.
The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RTSA group | Experimental | Device: Reverse Total Shoulder ArthroplastyParticipants with a complex proximal humerus fracture given a RTSA |
| Hemiarthroplasty group | Active comparator | Device: HemiarthroplastyHistorical cohort of participants, operated with a hemiarthroplasty of the shoulder |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Fracture or fracture dislocation not suitable for non-operative treatment or for osteosynthesis due to displacement and comminution
- Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older.
- All patients, regardless of age, with an insufficient or irreparable rotator cuff
Key exclusion criteria (4 listed)
- Brachial plexus palsy
- Previous ipsilateral fracture of clavicula, scapula, or proximal humerus
- Cognitive disabilities or substance abuse enabling rehabilitation and follow-up
- Patients without a Danish civil registration number
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 |
|---|---|---|
| Reverse Total Shoulder ArthroplastyThe RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes. | Device | RTSA group |
| HemiarthroplastyThe shoulder hemiarthroplasty | Device | Hemiarthroplasty group |
Primary outcome
Change in Constant score (CS)
Time frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
The CS consists of four parameters (pain, mobility, ADL, strength) assessing shoulder function after the treatment of shoulder injury, both subjectively and objectively. The scale rates from worst (0) to best (100) quality of shoulder function.
6 secondary outcomes
Change in Oxford Shoulder Score (OSS)
Time frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Time frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Change in EQ5D questionnaire
Time frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Change in Numeric Ranking Scale
Time frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Complications
Time frame: The outcome is registered 2 years after surgery
Change in humeral tuberosities
Time frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Shoulder Fractures
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
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SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
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Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
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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.
Bo S Olsen, Professor study chair
Herlev and Gentofte Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Reverse Total Shoulder Arthroplasty and Hemiarthroplasty in people with Shoulder Fractures, run by Signe Rosner Rasmussen.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Signe R Rasmussen, MD (+4526623427, signe.nanna.rosner.rasmussen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Constant score (CS) (time frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery). 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 11 Aug 2020.