The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus

University of Helsinki

Status: Terminated

Conditions: Humeral Fracture

Treatments: Procedure: Standard mobilisation after locking plate osteosynthesis; Procedure: Immediate mobilisation after locking-plate osteosynthesis; Device: Osteosynthesis with a locking plate (Philos)

Study type: Interventional

Funder types: Other

Identifiers

NCT01524965

HUS-272/13/03/02/2010

Details and patient eligibility

About

Open reduction and locking plate osteosynthesis is a commonly used and well-accepted treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff despite intensive rehabilitation, limiting the function of the upper extremity and decreasing the quality of life. The accepted postoperative mobilisation protocol includes passive exercises until six weeks postoperatively and active range of motion exercises after that. There is good evidence that conservatively treated fractures of the same site heal better and faster if mobilised immediately. The study compares "standard mobilisation" versus "immmediate mobilisation" in a prospective, randomized, controlled trial in order to find the optimal time-frame for physiotherapy to produce best possible results. Outcome measures are assessed at specific time points after the operation and comparisons between groups are made to follow the rate of recovery and end results.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• Surgery can be performed within 10 days of injury
• A dislocated (>1cm or 35 degrees) AO 11-A2, -A3, -B1 or -B2 fracture of the surgical neck of the proximal humerus with a possible fracture of the Tuberculum Majus

Exclusion criteria

• Glenohumeral dislocation
• Fracture of the Tuberculum Minus
• Open fracture
• Additional fractures in the shoulder region
• Other injuries requiring surgical treatment
• Clinically significant injury of the brachial plexus or vasculature
• Pathological fracture associated with cancer
• History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc)
• Rheumatoid Arthritis in the shoulder requiring active treatment
• Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc)
• Unwillingness to accept some of the treatment options.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups

Immediate mobilisation

Experimental group

Treatment:

Device: Osteosynthesis with a locking plate (Philos)

Procedure: Immediate mobilisation after locking-plate osteosynthesis

Standard mobilisation

Active Comparator group

Treatment:

Device: Osteosynthesis with a locking plate (Philos)

Procedure: Standard mobilisation after locking plate osteosynthesis