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

NCT01524965 | Terminated

• 1 other identifier: HUS-272/13/03/02/2010
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Keywords

Locking Plate; Physiotherapy

Outcome Measures

Primary Outcomes (6)

• Disablities of Arm, Hand and Shoulder

  Validated patient-reported upper extremity function scale

  3 weeks

• Disablities of Arm, Hand and Shoulder

  Validated patient-reported upper extremity function scale

  6 weeks

• Disablities of Arm, Hand and Shoulder

  Validated patient-reported upper extremity function scale

  3 months

• Disablities of Arm, Hand and Shoulder

  Validated patient-reported upper extremity function scale

  6 months

• Disablities of Arm, Hand and Shoulder

  Validated patient-reported upper extremity function scale

  1 year

• Disablities of Arm, Hand and Shoulder

  Validated patient-reported upper extremity function scale

  2 years

Secondary Outcomes (6)

• Constant Score

  3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

• Simple Shoulder Test (SST)

  3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

• Pain in rest and motion (2 different values)

  3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

• Subjective satisfaction

  3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

• Quality of Life

  3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

Study Arms (2)

Immediate mobilisation

EXPERIMENTAL

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

Standard mobilisation

ACTIVE COMPARATOR

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

Interventions

Immediate mobilisation after locking-plate osteosynthesis 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.

Immediate mobilisation

Standard mobilisation after locking plate osteosynthesis 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.

Standard mobilisation

Osteosynthesis with a locking plate (Philos) 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.

Immediate mobilisation; Standard mobilisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Helsinki: lead
• Finnish Institute for Health and Welfare: collaborator

Study Sites (1)

Töölö Hospital, Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Related Publications (1)

• 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.

  PMID: 35727196 DERIVED

MeSH Terms

Conditions

Humeral Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Tuomas Lähdeoja, MD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Mika Paavola, MD, PhD

  Helsinki University Central Hospital

  STUDY DIRECTOR

• Jarkko Pajarinen, MD, PhD

  Helsinki University Central Hospital

  STUDY DIRECTOR

• Seppo Koskinen

  Helsinki University Central Hospital

  STUDY CHAIR

• Antti Malmivaara, MD, PhD

  Finnish Institute for Health and Welfare

  STUDY CHAIR

• Reijo Sund, MD, PhD

  Finnish Institute for Health and Welfare

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 22, 2012
• First Posted: February 2, 2012
• Study Start: May 1, 2011
• Primary Completion: October 11, 2023
• Study Completion: October 21, 2023
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

FI (1)