Osteoarthritis of the ShoulderNCT02052206
Reconstruction of Complex Proximal Humeral Fractures.
A study testing Shoulder replacement surgery in people with Osteoarthritis of the Shoulder and Complexe Proximal Humeral Fractures, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate the accuracy of shoulder replacement surgery in realization a computer assisted 3D planning compared to conventional 2D planning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Shoulder, Complexe Proximal Humeral Fractures
- What is being tested?
- Shoulder replacement surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2014to Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis or complexe proximal humeral fracture and indication for shoulder arthroplasty
- patients > 18years
Who cannot join
- contraindication for computertomography
- pregnancy
- previous fracture or shoulder replacement of the contralateral side in case of a complexe proximal humeral fracture
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the accuracy of shoulder replacement surgery in realization a computer assisted 3D planning compared to conventional 2D planning.
- Being tested
- Shoulder replacement surgery
- Keywords
- osteoarthritis, complexe proximal humeral fracture, shoulder, shoulder replacement, accuracy, computer-assisted, 3D
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder replacement surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Computer-assisted 3D planning | Experimental | Realization of the fracture reconstruction according to the computer-assisted 3D preoperative plan Receives: Procedure: Shoulder replacement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative analysis of the accuracy of an automatic algorithm for the reconstruction of proximal humeral fractures
Accuracy of the reconstruction of complex proximal humeral fractures.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the ShoulderStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lazaros Vlachopoulos, MD, Balgrist University Hospital
- Investigators
- Lazaros Vlachopoulos, MD, Study chair, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052206
- Sponsor's protocol ID
- BalgristUH_CARD_03
- Status last verified
- Nov 2017
- First submitted
- 30 Jan 2014
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PubMed 35727196
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Complex Proximal Humeral Fractures.
- ClinicalTrials.gov ID
- NCT02052206
- Acronym / sponsor ID
- BalgristUH_CARD_03
- Keywords
- osteoarthritis, complexe proximal humeral fracture, shoulder, shoulder replacement, accuracy, computer-assisted, 3D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 3 Feb 2014 (estimated)
- 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 purpose of this study is to evaluate the accuracy of shoulder replacement surgery in realization a computer assisted 3D planning compared to conventional 2D planning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computer-assisted 3D planning | Experimental | Procedure: Shoulder replacement surgeryRealization of the fracture reconstruction according to the computer-assisted 3D preoperative plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- osteoarthritis or complexe proximal humeral fracture and indication for shoulder arthroplasty
- patients > 18years
Key exclusion criteria (3 listed)
- contraindication for computertomography
- pregnancy
- previous fracture or shoulder replacement of the contralateral side in case of a complexe proximal humeral fracture
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 |
|---|---|---|
| Shoulder replacement surgery | Procedure or surgery | Computer-assisted 3D planning |
Primary outcome
Quantitative analysis of the accuracy of an automatic algorithm for the reconstruction of proximal humeral fractures
Time frame: 6 weeks
Accuracy of the reconstruction of complex proximal humeral fractures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Derived from this study: PubMed 35727196Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
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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.
Lazaros Vlachopoulos, MD study chair
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder replacement surgery in people with Osteoarthritis of the Shoulder and Complexe Proximal Humeral Fractures, run by Balgrist University Hospital 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 27 Nov 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantitative analysis of the accuracy of an automatic algorithm for the reconstruction of proximal humeral fractures (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02052206, which also lists 1 linked publication.
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 Nov 2017.