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Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture

Primary Purpose

Fracture of Proximal Humerus

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PHILOS™ locked plate system by Synthes Canada©
Early and intensive exercise program
Standard rehabilitation program
Sponsored by
Hopital de l'Enfant-Jesus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Proximal Humerus focused on measuring humerus fracture, locked plate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHA-Pavillon Enfant-JésusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intensive Rehabilitation

Standard Rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Proportion of reoperation
The rate of complications such as infection, implant removal, implant failure and necrosis which necessitate additional surgery.
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.
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
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
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
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
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.
Quality of life on DASH scale
The quality of life is measured using the DASH scale 3 months after surgery.
Quality of life on DASH scale
Quality of life is measured using the DASH scale 6 months after surgery.
Quality of life on DASH scale
Quality of life is measured using the DASH scale 12 months after surgery.
Return to professional activities
This will be determined in days after surgery, to rates of 50% and 100% of the usual workload.
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.
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.
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.
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.
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 °).
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 °).
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 °).

Full Information

First Posted
April 28, 2010
Last Updated
December 19, 2012
Sponsor
Hopital de l'Enfant-Jesus
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1. Study Identification

Unique Protocol Identification Number
NCT01113411
Brief Title
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

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital de l'Enfant-Jesus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Proximal Humerus
Keywords
humerus fracture, locked plate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive Rehabilitation
Arm Type
Active Comparator
Arm Title
Standard Rehabilitation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
PHILOS™ locked plate system by Synthes Canada©
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Early and intensive exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard rehabilitation program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional outcome on Constant score
Description
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).
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Proportion of reoperation
Description
The rate of complications such as infection, implant removal, implant failure and necrosis which necessitate additional surgery.
Time Frame
within the first year following surgery
Title
Loss of radiological reduction
Description
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.
Time Frame
1 or 2 days after surgery
Title
Loss of radiological reduction
Description
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
Time Frame
10-14 days after surgery
Title
Loss of radiological reduction
Description
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
Time Frame
3 or 4 months after surgery
Title
Loss of radiological reduction
Description
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
Time Frame
6 months after surgery
Title
Loss of radiological reduction
Description
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
Time Frame
12 months after surgery
Title
Sustainability of the efficacy on Constant score
Description
Constant score will be measured one year after surgery to demonstrate the sustainability of the efficacy of intensive rehabilitation.
Time Frame
12 months after surgery
Title
Quality of life on DASH scale
Description
The quality of life is measured using the DASH scale 3 months after surgery.
Time Frame
3 months after surgery
Title
Quality of life on DASH scale
Description
Quality of life is measured using the DASH scale 6 months after surgery.
Time Frame
6 months after surgery
Title
Quality of life on DASH scale
Description
Quality of life is measured using the DASH scale 12 months after surgery.
Time Frame
12 months after surgery
Title
Return to professional activities
Description
This will be determined in days after surgery, to rates of 50% and 100% of the usual workload.
Time Frame
3 or 4 months after surgery
Title
Pain on visual analog scale (VAS)
Description
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.
Time Frame
10-14 days after surgery
Title
Pain on VAS
Description
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.
Time Frame
3 or 4 months after surgery
Title
Pain on VAS
Description
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.
Time Frame
6 months after surgery
Title
Pain on VAS
Description
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.
Time Frame
12 months after surgery
Title
Measurement of range of motion of shoulder
Description
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 °).
Time Frame
3 months after surgery
Title
Measurement of range of motion of shoulder
Description
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 °).
Time Frame
6 months after surgery
Title
Measurement of range of motion of shoulder
Description
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 °).
Time Frame
12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène Côté, Reg. Nurse
Phone
1-418-649-0252
Ext
3165
Email
helco3@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane Pelet, MD, PhD
Phone
1-418-649-0252
Ext
3165
Email
stephane.pelet.ortho@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Pelet, MD, PhD
Organizational Affiliation
Hôpital Enfant-Jésus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annie Arteau, MD
Organizational Affiliation
Hôpital Enfant-Jésus
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA-Pavillon Enfant-Jésus
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane Pelet, MD, PhD
Phone
418-649-0252
Ext
3165
Email
stephane.pelet.ortho@gmail.com
First Name & Middle Initial & Last Name & Degree
Stéphane Pelet, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35727196
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.
Results Reference
derived

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Effectiveness of Intensive Rehabilitation on Shoulder Function After Proximal Humerus Fracture

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