Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture
NCT ID: NCT01113411
Last Updated: 2012-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2009-12-31
2013-12-31
Brief Summary
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The objective of this study is to demonstrate the potential benefits of an early rehabilitation program on shoulder function.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intensive Rehabilitation
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.
Early and intensive exercise program
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
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.
Standard rehabilitation program
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.
Interventions
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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.
Early and intensive exercise program
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 program
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hopital de l'Enfant-Jesus
OTHER
Responsible Party
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Pelet Stephane
Dr Stephane Pelet MD, PhD Orthopedic surgeon
Principal Investigators
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Stéphane Pelet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Enfant-Jésus
Annie Arteau, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Enfant-Jésus
Locations
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CHA-Pavillon Enfant-Jésus
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Stephane Pelet, MD, PhD
Role: primary
References
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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.
Other Identifiers
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PEJ-525
Identifier Type: -
Identifier Source: org_study_id