Clinical trial NCT01113411: Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture
Official title: Effectiveness of Intensive Rehabilitation on Shoulder Function After a Fracture of the Proximal Humerus Treated by Locked Plate. A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture of Proximal Humerus
Keywords: humerus fracture
locked plate
Lead sponsor: Hopital de l'Enfant-Jesus
Sponsor class: OTHER
First posted: 2010-04-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Any other condition which prevents the assessor from fully monitoring the patient during study.

Primary outcomes:
measure: Functional outcome on Constant score
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Proportion of reoperation
timeFrame: within the first year following surgery
measure: Loss of radiological reduction
timeFrame: 1 or 2 days after surgery
measure: Loss of radiological reduction
timeFrame: 10-14 days after surgery
measure: Loss of radiological reduction
timeFrame: 3 or 4 months after surgery
measure: Loss of radiological reduction
timeFrame: 6 months after surgery
measure: Loss of radiological reduction
timeFrame: 12 months after surgery
measure: Sustainability of the efficacy on Constant score
timeFrame: 12 months after surgery
measure: Quality of life on DASH scale
timeFrame: 3 months after surgery
measure: Quality of life on DASH scale
timeFrame: 6 months after surgery
measure: Quality of life on DASH scale
timeFrame: 12 months after surgery
measure: Return to professional activities
timeFrame: 3 or 4 months after surgery
measure: Pain on visual analog scale (VAS)
timeFrame: 10-14 days after surgery
measure: Pain on VAS
timeFrame: 3 or 4 months after surgery
measure: Pain on VAS
timeFrame: 6 months after surgery
measure: Pain on VAS
timeFrame: 12 months after surgery
measure: Measurement of range of motion of shoulder
timeFrame: 3 months after surgery
measure: Measurement of range of motion of shoulder
timeFrame: 6 months after surgery
measure: Measurement of range of motion of shoulder
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CHA-Pavillon Enfant-Jésus
state: Quebec
Study officials:
affiliation: Hôpital Enfant-Jésus
name: Stéphane Pelet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Enfant-Jésus
name: Annie Arteau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.