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

Humeral Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01524965
• Other study ID #: HUS-272/13/03/02/2010
• Status: Recruiting
• Phase: N/A
• Start date: May 2011
• Est. completion date: December 2022

Study information

• Verified date: May 2020
• Source: University of Helsinki
• Contact: Tuomas Lähdeoja, MD
• Phone: +35894711
• Email: tuomas.lahdeoja[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fracture
• Humeral Fractures

Intervention

Procedure:
• Immediate mobilisation after locking-plate osteosynthesis
Immediate passive range of motion exercises are begun postoperatively, after 3 weeks, active unloaded mobilisation begins after three weeks and active, loaded use is allowed 6 weeks postoperatively. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.
• Standard mobilisation after locking plate osteosynthesis
Immediately postoperatively the arm is held in a sling, active mobilisation of healthy joints and pendel exercises are befun. Passive range of motion exercises of the shoulder are begun 3 weeks postoperatively. Active mobilisation begins after six weeks. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.

Device:
• Osteosynthesis with a locking plate (Philos)
Standard open reduction and internal fixation using a deltopectoral approach. Fracture fixation is done using a locking plate (Philos, Synthes) following the AO principles of fracture management.

Locations

Country	Name	City	State
Finland	Töölö Hospital, Helsinki University Central Hospital	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
University of Helsinki	National Institute for Health and Welfare, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disablities of Arm, Hand and Shoulder	Validated patient-reported upper extremity function scale	3 weeks
Primary	Disablities of Arm, Hand and Shoulder	Validated patient-reported upper extremity function scale	6 weeks
Primary	Disablities of Arm, Hand and Shoulder	Validated patient-reported upper extremity function scale	3 months
Primary	Disablities of Arm, Hand and Shoulder	Validated patient-reported upper extremity function scale	6 months
Primary	Disablities of Arm, Hand and Shoulder	Validated patient-reported upper extremity function scale	1 year
Primary	Disablities of Arm, Hand and Shoulder	Validated patient-reported upper extremity function scale	2 years
Secondary	Constant Score	subjective and objective shoulder score	3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Secondary	Simple Shoulder Test (SST)	another shoulder score	3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Secondary	Pain in rest and motion (2 different values)	Numeric rating scale 0-10	3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Secondary	Subjective satisfaction	Patient reported, Numeric Rating Scale 0-10	3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Secondary	Quality of Life	Using the 15D instrument	3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Secondary	Complications	Complications of surgery and postoperative phase	3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years