Proximal Humeral FractureROTATENCT02073695
Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace
A study testing Operative procedure to fix proximal humeral, Neutral Rotation Brace and Physiotherapy review in people with Proximal Humeral Fracture, run by Torbay and South Devon NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Research question: Do patients using a neutral rotation brace post surgery have improved functional outcome and external rotation of the shoulder compared to current best practice using a polysling holding the proximal humerus in internal rotation? Primary objectives: To compare post-operative functional outcome… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- Operative procedure to fix proximal humeral, Neutral Rotation Brace and Physiotherapy review
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Dec 2013
- 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
- Proximal humeral fractures requiring operative intervention with extramedullary plate fixation (i.e. fractures displaced by 1cm and/or angulated by 45 degrees or more)
- Age over 18 years of age
- Patient able to give informed consent
Who cannot join
- Patients having intra-operative findings to complete Pectoralis major rupture or if operative exposure requires complete Pectoralis major tenotomy. (These patients need to be held in internal rotation with a standard polysling to allow healing of the Pectoralis major tendon)
- Patients under 18 years of age
- Patients unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Research question:
Do patients using a neutral rotation brace post surgery have improved functional outcome and external rotation of the shoulder compared to current best practice using a polysling holding the proximal humerus in internal rotation?
Read more
Primary objectives:
To compare post-operative functional outcome scores obtained at 6 weeks, 9 weeks, 3 months and 1 year. (Scores at 6 weeks and 3 months in clinical review and postal scores at 9 weeks and 1 year) between patients held in neutral versus current standard rotation. These will be compared to scores taken pre-operatively.
Benefits:
There may be no extra benefits to patients from this trial however the results from the trial will help improve treatment for future patients at this hospital, and others across the country.
Risks/disadvantages:
The operation is the same in both groups studied, the study is investigating the use of the two different slings. The post-operative treatment is also the same, and all patients on the trial will receive the same amount of physiotherapy. It isn't anticipated that there will be any additional risk from this trial.
- Conditions
- Proximal Humeral Fracture
- Being tested
- Operative procedure to fix proximal humeral, Neutral Rotation Brace, Physiotherapy review, Functional outcome forms filled in, Postal functional outcome scores
- Keywords
- Proximal humeral fracture, Shoulder, Orthopaedics, Neutral rotation brace, Polysling
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative procedure to fix proximal humeralProcedure or surgery
Operative fixation by the shoulder team at Torbay Hospital
Neutral Rotation BraceDevice
Performed at the end of the surgical procedure at Torbay Hospital
Physiotherapy reviewOther
Physiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year.
Functional outcome forms filled inOther
Also called Oxford, DASH, SF-12
Postal functional outcome scoresOther
Sent to patient at 9 weeks post surgery
Post-operative RadiographsOther
Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital
| Study group | Role | What they receive |
|---|---|---|
| Neutral Rotation Brace | Other | Neutral Rotation Brace Receives: Procedure: Operative procedure to fix proximal humeral; Device: Neutral Rotation Brace; Other: Physiotherapy review; Other: Functional outcome forms filled in; Other: Postal functional outcome scores; Other: Post-operative Radiographs |
| Standard polysling (Current practice) | Other | Standard polysling (Current practice) Receives: Procedure: Operative procedure to fix proximal humeral; Device: Neutral Rotation Brace; Other: Physiotherapy review; Other: Functional outcome forms filled in; Other: Postal functional outcome scores; Other: Post-operative Radiographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford score
Patients subjective assessment of pain and Activities of Daily Living (ADL) impairment. The Oxford Shoulder Questionnaire has been shown to correlate well with both the Constant Score and the SF36 assessment and to be sensitive to surgical intervention. The Oxford Shoulder Questionnaire accumulates to a total score with a maximum of value of 60, in which four pain related questions make up 33% of this total whilst the remaining 67% is derived from eight ADL related questions. The highest scores are attributed to the worst outcomes in the Oxford Shoulder Questionnaire
Measured: 1 Year post surgery
DASH - the Disabilities of the Arm, Shoulder and Hand
DASH Scoring system was developed to assess the level of disability for any patient with any condition affecting the upper limb by covering domains including symptoms, physical function and psychological function
Measured: 1 year post surgery
Secondary outcomes (6)
Range of movement(flexion, extension, abduction, external and internal rotation)
Assessed by Physiotherapists. Measurement will be performed using a goniometer to accurately assess range of movement
Measured: 6 weeks, 3 months and 1 year
SF-12 Score
This survey form has been shown to yield summary physical and mental health outcome scores
Measured: 1 Year post surgery
Range of movement (flexion, extension, abduction and internal rotation)
Conducted by physiotherapists. Measured using a goniometer to accurately assess range of movement
Measured: 6 weeks, 6 months and 1 year
Time to union of fracture
X-Rays taken
Measured: 6 weeks and 3 Months
Return to work post surgery
Measured: 1 year follow up
Re-operations and Complications
Documented at various outpatient appointments
Measured: Throughout 1st year as applicable at outpatient appointments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: A publication released shortly after start indicating intervention not always beneficial. Fewer surgical cased thereafter.
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 Proximal Humeral FractureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torbay and South Devon NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronica Conboy, FRCS (Orth), Principal investigator, South Devon Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073695
- Sponsor's protocol ID
- 13/01/049
- Acronym
- ROTATE
- Status last verified
- Jul 2019
- First submitted
- 21 Feb 2014
- Last updated
- 18 Jul 2019
- 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 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace
- ClinicalTrials.gov ID
- NCT02073695
- Acronym / sponsor ID
- ROTATE / 13/01/049
- Conditions
- Proximal Humeral Fracture
- Keywords
- Proximal humeral fracture, Shoulder, Orthopaedics, Neutral rotation brace, Polysling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A publication released shortly after start indicating intervention not always beneficial. Fewer surgical cased thereafter.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Torbay and South Devon NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 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.
Research question:
Do patients using a neutral rotation brace post surgery have improved functional outcome and external rotation of the shoulder compared to current best practice using a polysling holding the proximal humerus in internal rotation?
Primary objectives:
To compare post-operative functional outcome scores obtained at 6 weeks, 9 weeks, 3 months and 1 year. (Scores at 6 weeks and 3 months in clinical review and postal scores at 9 weeks and 1 year) between patients held in neutral versus current standard rotation. These will be compared to scores taken pre-operatively.
Benefits:
There may be no extra benefits to patients from this trial however the results from the trial will help improve treatment for future patients at this hospital, and others across the country.
Risks/disadvantages:
The operation is the same in both groups studied, the study is investigating the use of the two different slings. The post-operative treatment is also the same, and all patients on the trial will receive the same amount of physiotherapy. It isn't anticipated that there will be any additional risk from this trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutral Rotation Brace | Other | Procedure: Operative procedure to fix proximal humeral, Device: Neutral Rotation Brace, Other: Physiotherapy review, Other: Functional outcome forms filled in, Other: Postal functional outcome scores, Other: Post-operative RadiographsNeutral Rotation Brace |
| Standard polysling (Current practice) | Other | Procedure: Operative procedure to fix proximal humeral, Device: Neutral Rotation Brace, Other: Physiotherapy review, Other: Functional outcome forms filled in, Other: Postal functional outcome scores, Other: Post-operative RadiographsStandard polysling (Current practice) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Proximal humeral fractures requiring operative intervention with extramedullary plate fixation (i.e. fractures displaced by 1cm and/or angulated by 45 degrees or more)
- Age over 18 years of age
- Patient able to give informed consent
Key exclusion criteria (3 listed)
- Patients having intra-operative findings to complete Pectoralis major rupture or if operative exposure requires complete Pectoralis major tenotomy. (These patients need to be held in internal rotation with a standard polysling to allow healing of the Pectoralis major tendon)
- Patients under 18 years of age
- Patients unable to give informed consent
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 |
|---|---|---|
| Operative procedure to fix proximal humeralOperative fixation by the shoulder team at Torbay Hospital | Procedure or surgery | Neutral Rotation Brace, Standard polysling (Current practice) |
| Neutral Rotation BracePerformed at the end of the surgical procedure at Torbay Hospital | Device | Neutral Rotation Brace, Standard polysling (Current practice) |
| Physiotherapy reviewPhysiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year. | Other | Neutral Rotation Brace, Standard polysling (Current practice) |
| Functional outcome forms filled inAlso: Oxford, DASH, SF-12 | Other | Neutral Rotation Brace, Standard polysling (Current practice) |
| Postal functional outcome scoresSent to patient at 9 weeks post surgery | Other | Neutral Rotation Brace, Standard polysling (Current practice) |
| Post-operative RadiographsPerformed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital | Other | Neutral Rotation Brace, Standard polysling (Current practice) |
Primary outcome
Oxford score
Time frame: 1 Year post surgery
Patients subjective assessment of pain and Activities of Daily Living (ADL) impairment. The Oxford Shoulder Questionnaire has been shown to correlate well with both the Constant Score and the SF36 assessment and to be sensitive to surgical intervention. The Oxford Shoulder Questionnaire accumulates to a total score with a maximum of value of 60, in which four pain related questions make up 33% of this total whilst the remaining 67% is derived from eight ADL related questions. The highest scores are attributed to the worst outcomes in the Oxford Shoulder Questionnaire
DASH - the Disabilities of the Arm, Shoulder and Hand
Time frame: 1 year post surgery
DASH Scoring system was developed to assess the level of disability for any patient with any condition affecting the upper limb by covering domains including symptoms, physical function and psychological function
6 secondary outcomes
Range of movement(flexion, extension, abduction, external and internal rotation)
Time frame: 6 weeks, 3 months and 1 year
SF-12 Score
Time frame: 1 Year post surgery
Range of movement (flexion, extension, abduction and internal rotation)
Time frame: 6 weeks, 6 months and 1 year
Time to union of fracture
Time frame: 6 weeks and 3 Months
Return to work post surgery
Time frame: 1 year follow up
Re-operations and Complications
Time frame: Throughout 1st year as applicable at outpatient appointments
Results and safety
The study was stopped early (reason given: A publication released shortly after start indicating intervention not always beneficial. Fewer surgical cased thereafter.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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.
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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.
Veronica Conboy, FRCS (Orth) principal investigator
South Devon Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operative procedure to fix proximal humeral, Neutral Rotation Brace and Physiotherapy review in people with Proximal Humeral Fracture, run by Torbay and South Devon NHS Foundation Trust at 1 site in United Kingdom.
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 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: stopped early, as of the sponsor's last update on 18 Jul 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 United Kingdom. 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: A publication released shortly after start indicating intervention not always beneficial. Fewer surgical cased thereafter.). 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?
Oxford score (time frame: 1 Year post surgery). The study lists 2 primary outcomes in all. 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 NCT02073695, 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 18 Jul 2019.