Shoulder FracturesNCT03217344
Conservative Treatment of Proximal Humeral Fractures
A study testing conservative treatment in people with Shoulder Fractures, run by Hospital del Mar at 1 site in Spain.
Trial summary
Optimal treatment of proximal humeral fractures is yet to be defined. Many of them can be treated non-operatively. The question remains on how long do we have to immobilize non-operatively treated proximal humeral fractures? Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Shoulder Fractures
- What is being tested?
- conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 19 Oct 2015to 20 Jun 2018
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 60 yo and < 85 yo
- Acute fractures less than 1 week evolution
- Conservative treatment decided by orthopedic surgeon
- Contact between humeral head and humeral shaft.
- No gleno-humeral dislocation
- No previous surgery
Who cannot join
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conservative Treatment of Proximal Humeral Fractures - Immobilization for 1 Week Compared to Three Weeks: Prospective Randomized Study
Optimal treatment of proximal humeral fractures is yet to be defined. Many of them can be treated non-operatively. The question remains on how long do we have to immobilize non-operatively treated proximal humeral fractures?
Read the detailed description
There is still controversy on best treatment of proximal humeral fractures. While some authors propose surgical treatment other advocate for conservative treatment. Traditionally, fractures treated non-operatively undergo a 3-week period of immobilization followed by progressive rehabilitation program. Nevertheless, there is little evidence to support a 3-week immobilization period. The purpose of this study is to bring evidence to support either a 1-week immobilization or 3-week immobilization period in non-operatively treated proximal humeral fractures.
- Conditions
- Shoulder Fractures
- Being tested
- conservative treatment
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative treatmentProcedure or surgery
immobilization on sling of the injured arm
| Study group | Role | What they receive |
|---|---|---|
| 1-week | Experimental | patients undergoing 1-week immobilization period Receives: Procedure: conservative treatment |
| 3-week | Experimental | patients undergoing 3-week immobilization period Receives: Procedure: conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain (analogical pain scale)
pain assessment through all the follow-up through the analogical pain scale
Measured: 1 year
Secondary outcomes (2)
fragment displacement assessed through X-Ray exam
displacement of the fractured fragments within 3 months period assessed through X-Ray exam
Measured: 3 months
functional outcome
functional outcome measured through Constant Score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start19 Oct 2015
- Primary completion20 Jun 2018
- Study completion20 Jun 2018
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 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized without restrictions
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Torrens, Hospital del Mar
- Investigators
- Carlos Torrens, PhD, Principal investigator, Hospital Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217344
- Sponsor's protocol ID
- 2016/6588/I
- Status last verified
- Mar 2019
- First submitted
- 4 Jul 2017
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment of Proximal Humeral Fractures - Immobilization for 1 Week Compared to Three Weeks: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03217344
- Acronym / sponsor ID
- 2016/6588/I
- Conditions
- Shoulder Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 14 Jul 2017 (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.
Optimal treatment of proximal humeral fractures is yet to be defined. Many of them can be treated non-operatively. The question remains on how long do we have to immobilize non-operatively treated proximal humeral fractures?
Detailed description
There is still controversy on best treatment of proximal humeral fractures. While some authors propose surgical treatment other advocate for conservative treatment. Traditionally, fractures treated non-operatively undergo a 3-week period of immobilization followed by progressive rehabilitation program. Nevertheless, there is little evidence to support a 3-week immobilization period. The purpose of this study is to bring evidence to support either a 1-week immobilization or 3-week immobilization period in non-operatively treated proximal humeral fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized without restrictions
| Arm | Type | Receives |
|---|---|---|
| 1-week | Experimental | Procedure: conservative treatmentpatients undergoing 1-week immobilization period |
| 3-week | Experimental | Procedure: conservative treatmentpatients undergoing 3-week immobilization period |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥ 60 yo and < 85 yo
- Acute fractures less than 1 week evolution
- Conservative treatment decided by orthopedic surgeon
- Contact between humeral head and humeral shaft.
- No gleno-humeral dislocation
Key exclusion criteria (1 listed)
- Cognitive impairment
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 |
|---|---|---|
| conservative treatmentimmobilization on sling of the injured arm | Procedure or surgery | 1-week, 3-week |
Primary outcome
pain (analogical pain scale)
Time frame: 1 year
pain assessment through all the follow-up through the analogical pain scale
2 secondary outcomes
fragment displacement assessed through X-Ray exam
Time frame: 3 months
functional outcome
Time frame: 1 year
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 12 Mar 2019.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Carlos Torrens, PhD principal investigator
Hospital Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conservative treatment in people with Shoulder Fractures, run by Hospital del Mar at 1 site in Spain.
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 6 inclusion and 1 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 12 Mar 2019. 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 Spain. 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?
pain (analogical pain scale) (time frame: 1 year). 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 NCT03217344, 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 12 Mar 2019.