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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Helsinki University
Sponsor:
Collaborator:
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Tuomas Lahdeoja, Helsinki University
ClinicalTrials.gov Identifier:
NCT01524965
First received: January 22, 2012
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Humeral Fracture
Procedure: Immediate mobilisation after locking-plate osteosynthesis
Procedure: Standard mobilisation after locking plate osteosynthesis
Device: Osteosynthesis with a locking plate (Philos)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus.

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Disablities of Arm, Hand and Shoulder [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Validated patient-reported upper extremity function scale

  • Disablities of Arm, Hand and Shoulder [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Validated patient-reported upper extremity function scale

  • Disablities of Arm, Hand and Shoulder [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Validated patient-reported upper extremity function scale

  • Disablities of Arm, Hand and Shoulder [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Validated patient-reported upper extremity function scale

  • Disablities of Arm, Hand and Shoulder [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Validated patient-reported upper extremity function scale

  • Disablities of Arm, Hand and Shoulder [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Validated patient-reported upper extremity function scale


Secondary Outcome Measures:
  • Constant Score [ Time Frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    subjective and objective shoulder score

  • Simple Shoulder Test (SST) [ Time Frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    another shoulder score

  • Pain in rest and motion (2 different values) [ Time Frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    Numeric rating scale 0-10

  • Subjective satisfaction [ Time Frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    Patient reported, Numeric Rating Scale 0-10

  • Quality of Life [ Time Frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    Using the 15D instrument

  • Complications [ Time Frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]
    Complications of surgery and postoperative phase


Estimated Enrollment: 100
Study Start Date: May 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate mobilisation 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.

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.
Active Comparator: Standard mobilisation 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524965

Contacts
Contact: Tuomas Lähdeoja, MD +35894711 tuomas.lahdeoja@hus.fi
Contact: Mika Paavola, MD, PhD +35894711

Locations
Finland
Töölö Hospital, Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029
Contact: Jarkko Pajarinen, MD, PhD    +35894711    jarkko.pajarinen@hus.fi   
Sponsors and Collaborators
Helsinki University
National Institute for Health and Welfare, Finland
Investigators
Principal Investigator: Tuomas Lähdeoja, MD Helsinki University Central Hospital
Study Director: Mika Paavola, MD, PhD Helsinki University Central Hospital
Study Director: Jarkko Pajarinen, MD, PhD Helsinki University Central Hospital
Study Chair: Vesa Savolainen, MD, PhD Helsinki University Central Hospital
Study Chair: Jan-Magnus Björkenheim, MD, PhD Helsinki University Central Hospital
Study Chair: Seppo Koskinen Helsinki University Central Hospital
Study Chair: Antti Malmivaara, MD, PhD National Institute for Health and Welfare, Finland
Study Chair: Reijo Dund, MD, PhD National Institute for Health and Welfare, Finland
  More Information

No publications provided

Responsible Party: Tuomas Lahdeoja, MD, Helsinki University
ClinicalTrials.gov Identifier: NCT01524965     History of Changes
Other Study ID Numbers: HUS-272/13/03/02/2010
Study First Received: January 22, 2012
Last Updated: January 31, 2012
Health Authority: Finland: Ethics Committee
Finland: National Advisory Board on Health Care Ethics

Keywords provided by Helsinki University:
Locking Plate
Physiotherapy

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on July 24, 2014