Recruiting

Rehabilitation Program

Sponsor:

Hopital de l'Enfant-Jesus

Code:

NCT01113411

Conditions

Fracture of Proximal Humerus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PHILOS™ locked plate system by Synthes Canada©

Early and intensive exercise program

Standard rehabilitation program

Study Details

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.

Conditions

Fracture of Proximal Humerus

Study ID

NCT01113411

Start date

Dec, 2009

Status verified date

Dec, 2012

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intensive Rehabilitation

active comparator: Standard Rehabilitation

Interventions

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.

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.

Primary outcome measure

  • Functional outcome on Constant score [ Time Frame: 6 months after surgery ]

Central Contacts and Locations

Central contacts

Hélène Côté, Reg. Nurse

1-418-649-0252helco3@hotmail.com

Stéphane Pelet, MD, PhD

1-418-649-0252stephane.pelet.ortho@gmail.com

Locations

CHA-Pavillon Enfant-Jésus

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Stephane Pelet, MD, PhD

418-649-0252stephane.pelet.ortho@gmail.com

Principal Investigator:

Stéphane Pelet, MD, PhD

More Information

Sponsor

Hopital de l'Enfant-Jesus

Last update posted

Dec 20, 2012

Last verified

Dec, 2012

Keywords

  • humerus fracture
  • locked plate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hopital de l'Enfant-Jesus on 2012-12-20.