Clinical trial NCT01524965: The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus
Official title: The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Humeral Fracture
Keywords: Locking Plate
Physiotherapy
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Finnish Institute for Health and Welfare
First posted: 2012-02-02
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disablities of Arm, Hand and Shoulder
timeFrame: 3 weeks
measure: Disablities of Arm, Hand and Shoulder
timeFrame: 6 weeks
measure: Disablities of Arm, Hand and Shoulder
timeFrame: 3 months
measure: Disablities of Arm, Hand and Shoulder
timeFrame: 6 months
measure: Disablities of Arm, Hand and Shoulder
timeFrame: 1 year
measure: Disablities of Arm, Hand and Shoulder
timeFrame: 2 years
Secondary outcomes:
measure: Constant Score
timeFrame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Simple Shoulder Test (SST)
timeFrame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Pain in rest and motion (2 different values)
timeFrame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Subjective satisfaction
timeFrame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Quality of Life
timeFrame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Complications
timeFrame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Töölö Hospital, Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Tuomas Lähdeoja, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Mika Paavola, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Jarkko Pajarinen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Seppo Koskinen
role: STUDY_CHAIR
affiliation: Finnish Institute for Health and Welfare
name: Antti Malmivaara, MD, PhD
role: STUDY_CHAIR
affiliation: Finnish Institute for Health and Welfare
name: Reijo Sund, MD, PhD
role: STUDY_CHAIR
References:
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.