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

Primary Purpose

Humeral Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Immediate mobilisation after locking-plate osteosynthesis
Standard mobilisation after locking plate osteosynthesis
Osteosynthesis with a locking plate (Philos)
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humeral Fracture focused on measuring Locking Plate, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Töölö Hospital, Helsinki University Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate mobilisation

Standard mobilisation

Arm Description

Outcomes

Primary Outcome Measures

Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale

Secondary Outcome Measures

Constant Score
subjective and objective shoulder score
Simple Shoulder Test (SST)
another shoulder score
Pain in rest and motion (2 different values)
Numeric rating scale 0-10
Subjective satisfaction
Patient reported, Numeric Rating Scale 0-10
Quality of Life
Using the 15D instrument
Complications
Complications of surgery and postoperative phase

Full Information

First Posted
January 22, 2012
Last Updated
May 4, 2020
Sponsor
University of Helsinki
Collaborators
Finnish Institute for Health and Welfare
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1. Study Identification

Unique Protocol Identification Number
NCT01524965
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
Collaborators
Finnish Institute for Health and Welfare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Fracture
Keywords
Locking Plate, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate mobilisation
Arm Type
Experimental
Arm Title
Standard mobilisation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Immediate mobilisation after locking-plate osteosynthesis
Intervention Description
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
Intervention Name(s)
Standard mobilisation after locking plate osteosynthesis
Intervention Description
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
Device
Intervention Name(s)
Osteosynthesis with a locking plate (Philos)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disablities of Arm, Hand and Shoulder
Description
Validated patient-reported upper extremity function scale
Time Frame
3 weeks
Title
Disablities of Arm, Hand and Shoulder
Description
Validated patient-reported upper extremity function scale
Time Frame
6 weeks
Title
Disablities of Arm, Hand and Shoulder
Description
Validated patient-reported upper extremity function scale
Time Frame
3 months
Title
Disablities of Arm, Hand and Shoulder
Description
Validated patient-reported upper extremity function scale
Time Frame
6 months
Title
Disablities of Arm, Hand and Shoulder
Description
Validated patient-reported upper extremity function scale
Time Frame
1 year
Title
Disablities of Arm, Hand and Shoulder
Description
Validated patient-reported upper extremity function scale
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Constant Score
Description
subjective and objective shoulder score
Time Frame
3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Title
Simple Shoulder Test (SST)
Description
another shoulder score
Time Frame
3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Title
Pain in rest and motion (2 different values)
Description
Numeric rating scale 0-10
Time Frame
3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Title
Subjective satisfaction
Description
Patient reported, Numeric Rating Scale 0-10
Time Frame
3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Title
Quality of Life
Description
Using the 15D instrument
Time Frame
3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Title
Complications
Description
Complications of surgery and postoperative phase
Time Frame
3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuomas Lähdeoja, MD
Phone
+35894711
Email
tuomas.lahdeoja@hus.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Mika Paavola, MD, PhD
Phone
+35894711
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuomas Lähdeoja, MD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mika Paavola, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jarkko Pajarinen, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seppo Koskinen
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antti Malmivaara, MD, PhD
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Reijo Sund, MD, PhD
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Chair
Facility Information:
Facility Name
Töölö Hospital, Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarkko Pajarinen, MD, PhD
Phone
+35894711
Email
jarkko.pajarinen@hus.fi

12. IPD Sharing Statement

Citations:
PubMed Identifier
35727196
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.
Results Reference
derived

Learn more about this trial

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

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