Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture

Fracture of Proximal Humerus Clinical Trial

Official title:

Effectiveness of Intensive Rehabilitation on Shoulder Function After a Fracture of the Proximal Humerus Treated by Locked Plate. A Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01113411
• Other study ID #: PEJ-525
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2010
• Last updated: December 19, 2012
• Start date: December 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: Hopital de l'Enfant-Jesus
• Contact: Hélène Côté, Reg. Nurse
• Phone: 1-418-649-0252
• Email: helco3[@]hotmail.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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.

The objective of this study is to demonstrate the potential benefits of an early rehabilitation program on shoulder function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture of Proximal Humerus
• Fractures, Bone

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Canada	CHA-Pavillon Enfant-Jésus	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital de l'Enfant-Jesus

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of reoperation	The rate of complications such as infection, implant removal, implant failure and necrosis which necessitate additional surgery.	within the first year following surgery	No
Secondary	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.	1 or 2 days after surgery	No
Secondary	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	10-14 days after surgery	No
Secondary	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	3 or 4 months after surgery	No
Secondary	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	6 months after surgery	No
Secondary	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	12 months after surgery	No
Secondary	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.	12 months after surgery	No
Secondary	Quality of life on DASH scale	The quality of life is measured using the DASH scale 3 months after surgery.	3 months after surgery	No
Secondary	Quality of life on DASH scale	Quality of life is measured using the DASH scale 6 months after surgery.	6 months after surgery	No
Secondary	Quality of life on DASH scale	Quality of life is measured using the DASH scale 12 months after surgery.	12 months after surgery	No
Secondary	Return to professional activities	This will be determined in days after surgery, to rates of 50% and 100% of the usual workload.	3 or 4 months after surgery	No
Secondary	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.	10-14 days after surgery	No
Secondary	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.	3 or 4 months after surgery	No
Secondary	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.	6 months after surgery	No
Secondary	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.	12 months after surgery	No
Secondary	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 °).	3 months after surgery	No
Secondary	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 °).	6 months after surgery	No
Secondary	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 °).	12 months after surgery	No