Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture
1 other identifier
interventional
80
1 country
1
Brief 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. The objective of this study is to demonstrate the potential benefits of an early rehabilitation program on shoulder function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 28, 2010
CompletedFirst Posted
Study publicly available on registry
April 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 20, 2012
December 1, 2012
4 years
April 28, 2010
December 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
6 months after surgery
Secondary Outcomes (18)
Proportion of reoperation
within the first year following surgery
Loss of radiological reduction
1 or 2 days after surgery
Loss of radiological reduction
10-14 days after surgery
Loss of radiological reduction
3 or 4 months after surgery
Loss of radiological reduction
6 months after surgery
- +13 more secondary outcomes
Study Arms (2)
Intensive Rehabilitation
ACTIVE COMPARATORStandard Rehabilitation
ACTIVE COMPARATORInterventions
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.
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHA-Pavillon Enfant-Jésus
Québec, Quebec, G1J 1Z4, Canada
Related Publications (1)
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.
PMID: 35727196DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphane Pelet, MD, PhD
Hôpital Enfant-Jésus
- PRINCIPAL INVESTIGATOR
Annie Arteau, MD
Hôpital Enfant-Jésus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Stephane Pelet MD, PhD Orthopedic surgeon
Study Record Dates
First Submitted
April 28, 2010
First Posted
April 29, 2010
Study Start
December 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 20, 2012
Record last verified: 2012-12