Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture

Not Applicable

• Conditions: Fracture of Proximal Humerus
• Interventions: Device: PHILOS™ locked plate system by Synthes Canada©; Other: Early and intensive exercise program; Other: Standard rehabilitation program

• Registration Number: NCT01113411
• Lead Sponsor: Hopital de l'Enfant-Jesus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-29
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Rehabilitation	PHILOS™ locked plate system by Synthes Canada©	-
Intensive Rehabilitation	Early and intensive exercise program	-
Standard Rehabilitation	PHILOS™ locked plate system by Synthes Canada©	-
Standard Rehabilitation	Standard rehabilitation program	-

Primary Outcome Measures

Name	Time	Method
Functional outcome on Constant score	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).

Secondary Outcome Measures

Name	Time	Method
Proportion of reoperation	within the first year following surgery	The rate of complications such as infection, implant removal, implant failure and necrosis which necessitate additional surgery.
Loss of radiological reduction	12 months after surgery	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
Sustainability of the efficacy on Constant score	12 months after surgery	Constant score will be measured one year after surgery to demonstrate the sustainability of the efficacy of intensive rehabilitation.
Quality of life on DASH scale	12 months after surgery	Quality of life is measured using the DASH scale 12 months after surgery.
Return to professional activities	3 or 4 months after surgery	This will be determined in days after surgery, to rates of 50% and 100% of the usual workload.
Pain on visual analog scale (VAS)	10-14 days after surgery	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.
Pain on VAS	12 months after surgery	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.
Measurement of range of motion of shoulder	12 months after surgery	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 °).

Trial Locations

Locations (1)

CHA-Pavillon Enfant-Jésus; 🇨🇦 Québec, Quebec, Canada