Fracture of Proximal HumerusNCT01113411
Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture
A study testing PHILOS™ locked plate system by Synthes Canada©, Early and intensive exercise program and Standard rehabilitation program in people with Fracture of Proximal Humerus, run by Hopital de l'Enfant-Jesus at 1 site in Canada.
Trial summary
The fracture of the proximal humerus represents 4% of the fractures encountered in clinics and it must be treated surgically. Thus, the aim of the surgical treatment is to maintain bone alignment, articular congruity, vascularization of the humeral head and provide a painless shoulder with satisfactory function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Proximal Humerus
- What is being tested?
- PHILOS™ locked plate system by Synthes Canada©, Early and intensive exercise program and Standard rehabilitation program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2009to 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
- Male or female over 18 years
- Unstable fracture of the proximal humerus
- Two-part and three-part fractures according to the Neer classification
- Closed fracture
- Time between trauma and surgery less than or equal to 7 days
- Signing of consent form
Who cannot join
- Stable fracture of the proximal humerus (not requiring surgery)
- Four-part fracture on the Neer classification
- Fracture-dislocation or fracture involving the articular surface
- Isolated fracture of the large or small tuberosity
- Pathological fracture
- Fracture associated with neuro-vascular lesions
Show all 16Show fewer
- Bilateral fractures
- Fracture associated with long bones fracture
- Polytrauma
- Previous history of fracture or surgery to the ipsilateral proximal humerus
- Severe COPD
- Severe neuromuscular disorders (Parkinson, hemiparesis, myasthenia gravis, muscular dystrophy, etc. ...)
- Remote location of patient's home which makes it difficult to come to facility for follow-up visits
- Any medical condition making it impossible for the patient to perform the exercise program (Alzheimer, dementia, etc. ...)
- Man or woman incapacitated sign consent form
- Any other condition which prevents the assessor from fully monitoring the patient during study.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHA-Pavillon Enfant-Jésus
Québec, Quebec, G1J 1Z4
Stephane Pelet, MD, PhD, 418-649-0252 ext. 3165, stephane.pelet.ortho@gmail.com
Stéphane Pelet, MD, PhD
About this study
Official title: Effectiveness of Intensive Rehabilitation on Shoulder Function After a Fracture of the Proximal Humerus Treated by Locked Plate. A Prospective Randomized Study
The fracture of the proximal humerus represents 4% of the fractures encountered in clinics and it must be treated surgically. Thus, the aim of the surgical treatment is to maintain bone alignment, articular congruity, vascularization of the humeral head and provide a painless shoulder with satisfactory function.
The objective of this study is to demonstrate the potential benefits of an early rehabilitation program on shoulder function.
- Conditions
- Fracture of Proximal Humerus
- Being tested
- PHILOS™ locked plate system by Synthes Canada©, Early and intensive exercise program, Standard rehabilitation program
- Keywords
- humerus fracture, locked plate
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHILOS™ locked plate system by Synthes Canada©Device
The surgery will be performed under standardized general anesthetic with a prophylactic antibiotic. The deltopectoral approach is used in all cases. The fracture will be fixed using the PHILOS locked plate system by Synthes Canada ©. Some additional osteosutures may be used. The wound is irrigated and then closed in two layers at the end of intervention. A splint thoracic brace will be installed in all patients before the end of anesthesia.
Early and intensive exercise programOther
A thoraco brachial brace will be worn for 48 hours following the surgery and then removed for the remainder of treatment. Patients will then start the intensive rehabilitation program without physical therapy. The exercise program will be provided to the patient.
The exercises consist of active and active assisted movements of the shoulder for a period of six weeks, limiting external rotation to 0 °. Patients are encouraged to use their affected limb for daily activities. Strengthening exercises are started the 6th week following surgery and the full program will be completed three months after surgery. Patients who wish can then continue their rehabilitation with a physiotherapist.
The patient will complete a daily diary to validate the frequency and intensity of the exercises.
Standard rehabilitation programOther
The patient will wear the thoraco brachial brace for a period of four weeks following the surgery. It may be taken off for hygiene purposes and dressing up. After the four weeks, the patient will take the brace off permanently and begins an exercise program, writing down the frequency and intensity of the exercises. Physiotherapy is allowed for the remaining part of the three months rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Rehabilitation | Active comparator | Not described Receives: Device: PHILOS™ locked plate system by Synthes Canada©; Other: Early and intensive exercise program |
| Standard Rehabilitation | Active comparator | Not described Receives: Device: PHILOS™ locked plate system by Synthes Canada©; Other: Standard rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome on Constant score
The investigators will validate that early and intensive rehabilitation gives a better functional outcome at 6 months using the Constant score adjusted for age. A difference of 10 points is considered significant (standard deviation of 15 points).
Measured: 6 months after surgery
Secondary outcomes (18)
Proportion of reoperation
The rate of complications such as infection, implant removal, implant failure and necrosis which necessitate additional surgery.
Measured: within the first year following surgery
Loss of radiological reduction
The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique.
Measured: 1 or 2 days after surgery
Loss of radiological reduction
The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique
Measured: 10-14 days after surgery
Loss of radiological reduction
The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique
Measured: 3 or 4 months after surgery
Loss of radiological reduction
The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique
Measured: 6 months after surgery
Loss of radiological reduction
The main displacements occur in varus and it will be measured on a radiography on an AP view of Neer. The neck-shaft angle will be measured and a difference of 10 degrees will be considered significant to account for the lack of standardization of the radiological technique
Measured: 12 months after surgery
Sustainability of the efficacy on Constant score
Constant score will be measured one year after surgery to demonstrate the sustainability of the efficacy of intensive rehabilitation.
Measured: 12 months after surgery
Quality of life on DASH scale
The quality of life is measured using the DASH scale 3 months after surgery.
Measured: 3 months after surgery
Quality of life on DASH scale
Quality of life is measured using the DASH scale 6 months after surgery.
Measured: 6 months after surgery
Quality of life on DASH scale
Quality of life is measured using the DASH scale 12 months after surgery.
Measured: 12 months after surgery
Return to professional activities
This will be determined in days after surgery, to rates of 50% and 100% of the usual workload.
Measured: 3 or 4 months after surgery
Pain on visual analog scale (VAS)
The measure will be carried out using a suitable rule designed for this type of measurement, counting only full numbers from 1 to 10 on VAS.
Measured: 10-14 days after surgery
Pain on VAS
The measure will be carried out using a suitable rule designed for this type of measurement, counting only full numbers from 1 to 10 on VAS.
Measured: 3 or 4 months after surgery
Pain on VAS
The measure will be carried out using a suitable rule designed for this type of measurement, counting only full numbers from 1 to 10 on VAS.
Measured: 6 months after surgery
Pain on VAS
The measure will be carried out using a suitable rule designed for this type of measurement, counting only full numbers from 1 to 10 on VAS.
Measured: 12 months after surgery
Measurement of range of motion of shoulder
Using a goniometer, we will measure the bending (normal value 180 °), abduction (180 °), external rotation in the scapular plane (90 °) and internal rotation in the plane scapula (60 °).
Measured: 3 months after surgery
Measurement of range of motion of shoulder
Using a goniometer, we will measure the bending (normal value 180 °), abduction (180 °), external rotation in the scapular plane (90 °) and internal rotation in the plane scapula (60 °).
Measured: 6 months after surgery
Measurement of range of motion of shoulder
Using a goniometer, we will measure the bending (normal value 180 °), abduction (180 °), external rotation in the scapular plane (90 °) and internal rotation in the plane scapula (60 °).
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
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 Fracture of Proximal HumerusStudies 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital de l'Enfant-Jesus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelet Stephane, Hopital de l'Enfant-Jesus
- Investigators
- Stéphane Pelet, MD, PhD, Principal investigator, Hôpital Enfant-JésusAnnie Arteau, MD, Principal investigator, Hôpital Enfant-Jésus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113411
- Sponsor's protocol ID
- PEJ-525
- Status last verified
- Dec 2012
- First submitted
- 28 Apr 2010
- Last updated
- 20 Dec 2012
- 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 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intensive Rehabilitation on Shoulder Function After a Fracture of the Proximal Humerus Treated by Locked Plate. A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01113411
- Acronym / sponsor ID
- PEJ-525
- Conditions
- Fracture of Proximal Humerus
- Keywords
- humerus fracture, locked plate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hopital de l'Enfant-JesusUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 29 Apr 2010 (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 fracture of the proximal humerus represents 4% of the fractures encountered in clinics and it must be treated surgically. Thus, the aim of the surgical treatment is to maintain bone alignment, articular congruity, vascularization of the humeral head and provide a painless shoulder with satisfactory function.
The objective of this study is to demonstrate the potential benefits of an early rehabilitation program on shoulder function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Rehabilitation | Active comparator | Device: PHILOS™ locked plate system by Synthes Canada©, Other: Early and intensive exercise program |
| Standard Rehabilitation | Active comparator | Device: PHILOS™ locked plate system by Synthes Canada©, Other: Standard rehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female over 18 years
- Unstable fracture of the proximal humerus
- Two-part and three-part fractures according to the Neer classification
- Closed fracture
- Time between trauma and surgery less than or equal to 7 days
Key exclusion criteria (16 listed)
- Stable fracture of the proximal humerus (not requiring surgery)
- Four-part fracture on the Neer classification
- Fracture-dislocation or fracture involving the articular surface
- Isolated fracture of the large or small tuberosity
- Pathological 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 |
|---|---|---|
| PHILOS™ locked plate system by Synthes Canada©The surgery will be performed under standardized general anesthetic with a prophylactic antibiotic. The deltopectoral approach is used in all cases. The fracture will be fixed using the PHILOS locked plate system by Synthes Canada ©. Some additional osteosutures may be used. The wound is irrigated and then closed in two layers at the end of intervention. A splint thoracic brace will be installed in all patients before the end of anesthesia. | Device | Intensive Rehabilitation, Standard Rehabilitation |
| Early and intensive exercise programA thoraco brachial brace will be worn for 48 hours following the surgery and then removed for the remainder of treatment. Patients will then start the intensive rehabilitation program without physical therapy. The exercise program will be provided to the patient. The exercises consist of active and active assisted movements of the shoulder for a period of six weeks, limiting external rotation to 0 °. Patients are encouraged to use their affected limb for daily activities. Strengthening exercises are started the 6th week following surgery and the full program will be completed three months after surgery. Patients who wish can then continue their rehabilitation with a physiotherapist. The patient will complete a daily diary to validate the frequency and intensity of the exercises. | Other | Intensive Rehabilitation |
| Standard rehabilitation programThe patient will wear the thoraco brachial brace for a period of four weeks following the surgery. It may be taken off for hygiene purposes and dressing up. After the four weeks, the patient will take the brace off permanently and begins an exercise program, writing down the frequency and intensity of the exercises. Physiotherapy is allowed for the remaining part of the three months rehabilitation program. | Other | Standard Rehabilitation |
Primary outcome
Functional outcome on Constant score
Time frame: 6 months after surgery
The investigators will validate that early and intensive rehabilitation gives a better functional outcome at 6 months using the Constant score adjusted for age. A difference of 10 points is considered significant (standard deviation of 15 points).
18 secondary outcomes
Proportion of reoperation
Time frame: within the first year following surgery
Loss of radiological reduction
Time frame: 1 or 2 days after surgery
Loss of radiological reduction
Time frame: 10-14 days after surgery
Loss of radiological reduction
Time frame: 3 or 4 months after surgery
Loss of radiological reduction
Time frame: 6 months after surgery
Loss of radiological reduction
Time frame: 12 months after surgery
Sustainability of the efficacy on Constant score
Time frame: 12 months after surgery
Quality of life on DASH scale
Time frame: 3 months after surgery
Quality of life on DASH scale
Time frame: 6 months after surgery
Quality of life on DASH scale
Time frame: 12 months after surgery
Return to professional activities
Time frame: 3 or 4 months after surgery
Pain on visual analog scale (VAS)
Time frame: 10-14 days after surgery
Pain on VAS
Time frame: 3 or 4 months after surgery
Pain on VAS
Time frame: 6 months after surgery
Pain on VAS
Time frame: 12 months after surgery
Measurement of range of motion of shoulder
Time frame: 3 months after surgery
Measurement of range of motion of shoulder
Time frame: 6 months after surgery
Measurement of range of motion of shoulder
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
- 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.
Stéphane Pelet, MD, PhD principal investigator
Hôpital Enfant-Jésus
Annie Arteau, MD principal investigator
Hôpital Enfant-Jésus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHILOS™ locked plate system by Synthes Canada©, Early and intensive exercise program and Standard rehabilitation program in people with Fracture of Proximal Humerus, run by Hopital de l'Enfant-Jesus at 1 site in Canada.
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 16 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 20 Dec 2012. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hélène Côté, Reg. Nurse (1-418-649-0252 ext. 3165, helco3@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome on Constant score (time frame: 6 months after surgery). 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 NCT01113411, 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 20 Dec 2012.