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

April 28, 2010
December 19, 2012
December 2009
December 2013   (final data collection date for primary outcome measure)
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).
Functional outcome on Constant score [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
We 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).
Complete list of historical versions of study NCT01113411 on ClinicalTrials.gov Archive Site
  • 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 °).
  • 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: 3-4 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: 3-4 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: 3-4 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 °).
Not Provided
Not Provided
 
Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture
Effectiveness of Intensive Rehabilitation on Shoulder Function After a Fracture of the Proximal Humerus Treated by Locked Plate. A Prospective Randomized Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fracture of Proximal Humerus
  • 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.

  • 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.
  • Active Comparator: Intensive Rehabilitation
    Interventions:
    • Device: PHILOS™ locked plate system by Synthes Canada©
    • Other: Early and intensive exercise program
  • Active Comparator: Standard Rehabilitation
    Interventions:
    • Device: PHILOS™ locked plate system by Synthes Canada©
    • Other: Standard rehabilitation program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
Canada
 
NCT01113411
PEJ-525
No
Pelet Stephane, Hopital de l'Enfant-Jesus
Hopital de l'Enfant-Jesus
Not Provided
Principal Investigator: Stéphane Pelet, MD, PhD Hôpital Enfant-Jésus
Principal Investigator: Annie Arteau, MD Hôpital Enfant-Jésus
Hopital de l'Enfant-Jesus
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP