Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture

This study is currently recruiting participants.
Verified December 2012 by Hopital de l'Enfant-Jesus
Sponsor:
Information provided by (Responsible Party):
Pelet Stephane, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier:
NCT01113411
First received: April 28, 2010
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Fracture of Proximal Humerus
Device: PHILOS™ locked plate system by Synthes Canada©
Other: Early and intensive exercise program
Other: Standard rehabilitation program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Intensive Rehabilitation on Shoulder Function After a Fracture of the Proximal Humerus Treated by Locked Plate. A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Hopital de l'Enfant-Jesus:

Primary Outcome Measures:
  • Functional outcome on Constant score [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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:
  • Proportion of reoperation [ Time Frame: within the first year following surgery ] [ Designated as safety issue: No ]
    The rate of complications such as infection, implant removal, implant failure and necrosis which necessitate additional surgery.

  • Loss of radiological reduction [ Time Frame: 1 or 2 days after surgery ] [ Designated as safety issue: No ]
    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.

  • Loss of radiological reduction [ Time Frame: 10-14 days after surgery ] [ Designated as safety issue: No ]
    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

  • Loss of radiological reduction [ Time Frame: 3 or 4 months after surgery ] [ Designated as safety issue: No ]
    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

  • Loss of radiological reduction [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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

  • Loss of radiological reduction [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    The quality of life is measured using the DASH scale 3 months after surgery.

  • Quality of life on DASH scale [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    Quality of life is measured using the DASH scale 6 months after surgery.

  • Quality of life on DASH scale [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Quality of life is measured using the DASH scale 12 months after surgery.

  • Return to professional activities [ Time Frame: 3 or 4 months after surgery ] [ Designated as safety issue: No ]
    This will be determined in days after surgery, to rates of 50% and 100% of the usual workload.

  • Pain on visual analog scale (VAS) [ Time Frame: 10-14 days after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 or 4 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    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 °).

  • Measurement of range of motion of shoulder [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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 °).

  • Measurement of range of motion of shoulder [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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 °).


Estimated Enrollment: 80
Study Start Date: December 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intensive Rehabilitation 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.

Active Comparator: Standard Rehabilitation 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: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113411

Contacts
Contact: Hélène Côté, Reg. Nurse 1-418-649-0252 ext 3165 helco3@hotmail.com
Contact: Stéphane Pelet, MD, PhD 1-418-649-0252 ext 3165 stephane.pelet.ortho@gmail.com

Locations
Canada, Quebec
CHA-Pavillon Enfant-Jésus Recruiting
Québec, Quebec, Canada, G1J 1Z4
Contact: Stephane Pelet, MD, PhD    418-649-0252 ext 3165    stephane.pelet.ortho@gmail.com   
Principal Investigator: Stéphane Pelet, MD, PhD         
Sponsors and Collaborators
Hopital de l'Enfant-Jesus
Investigators
Principal Investigator: Stéphane Pelet, MD, PhD Hôpital Enfant-Jésus
Principal Investigator: Annie Arteau, MD Hôpital Enfant-Jésus
  More Information

No publications provided

Responsible Party: Pelet Stephane, Dr Stephane Pelet MD, PhD Orthopedic surgeon, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier: NCT01113411     History of Changes
Other Study ID Numbers: PEJ-525
Study First Received: April 28, 2010
Last Updated: December 19, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Hopital de l'Enfant-Jesus:
humerus fracture
locked plate

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on April 16, 2014