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

NCT ID: NCT01524965

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2023-10-21

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.

Conditions

Humeral Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immediate mobilisation

Group Type: EXPERIMENTAL

Immediate mobilisation after locking-plate osteosynthesis

Intervention Type: PROCEDURE

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.

Osteosynthesis with a locking plate (Philos)

Intervention Type: DEVICE

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.

Standard mobilisation

Group Type: ACTIVE_COMPARATOR

Standard mobilisation after locking plate osteosynthesis

Intervention Type: PROCEDURE

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.

Osteosynthesis with a locking plate (Philos)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: lead

Responsible Party

Tuomas Lahdeoja

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tuomas Lähdeoja, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Mika Paavola, MD, PhD

Role: STUDY_DIRECTOR

Helsinki University Central Hospital

Jarkko Pajarinen, MD, PhD

Role: STUDY_DIRECTOR

Helsinki University Central Hospital

Seppo Koskinen

Role: STUDY_CHAIR

Helsinki University Central Hospital

Antti Malmivaara, MD, PhD

Role: STUDY_CHAIR

Finnish Institute for Health and Welfare

Reijo Sund, MD, PhD

Role: STUDY_CHAIR

Finnish Institute for Health and Welfare

Locations

Töölö Hospital, Helsinki University Central Hospital

Helsinki, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 35727196 (View on PubMed)

Other Identifiers

HUS-272/13/03/02/2010

Identifier Type: -

Identifier Source: org_study_id