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Trochanteric Hip Fractures (AO A2) SHS With or Without Trochanteric Stabilizing Plate - Rct Using RSA

Primary Purpose

Hip Fractures, Trochanteric Fractures, Intertrochanteric Fractures

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Sliding Hip Screw with Trochanteric Stabilization Plate
Sliding Hip Screw without Trochanteric Stabilization Plate
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

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

Inclusion Criteria:

  • AO 31-A2
  • able to walk independently, aids such as crutches or walker allowed
  • able to consent
  • fit for surgery with SHS with or without TSP

Exclusion Criteria:

  • not willing or able to attain follow up
  • previous fracture or surgery with retained metal work in the same hip
  • concomitant disease that will shorten life expectancy

Sites / Locations

  • Orthopedic Center, Ulleval University Hospital
  • Diakonhjemmet Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SHS without TSP

SHS with TSP

Arm Description

Patients with AO 31 A2 trochanteric fractures operated with sliding hip screw without trochanteric stabilization plate.

Patients with AO 31 A2 trochanteric fractures operated with sliding hip screw with trochanteric stabilization plate.

Outcomes

Primary Outcome Measures

Fracture displacement during healing measured with radiostereometry
Will be measured by RSA postoperatively, before discharge and after 4, 8, 12, 24 and 52 weeks. Total displacement from first reading to the reading showing maximum displacement is the main outcome.

Secondary Outcome Measures

Perioperative blood loss
Time of surgery
Eq5d
Health Related Quality of Life (Hrqol).
Eq5d
Hrqol.
Eq5d
Hrqol.
Eq5d
Hrqol.
Eq5d
Hrqol.
Time to union as measured by RSA (cessation of motion) and radiographs
When RSA shows that no motion has happened between two time points the fracture will be regarded as healed at the former time point.
Time to union as measured by plain radiographs and clinical findings
Composite endpoint: Healing defined by obliteration of fracture line radiographically and pain free weight bearing (except lateral pain from hardware), when this occurs the fracture will be considered healed.
Harris Hip Score
Will be examined at 4, 8, 12, 26 and 52 weeks
Harris Hip Score
Will be examined at 4, 8, 12, 26 and 52 weeks
Harris Hip Score
Will be examined at 4, 8, 12, 26 and 52 weeks
Harris Hip Score
Will be examined at 4, 8, 12, 26 and 52 weeks
Harris Hip Score
Will be examined at 4, 8, 12, 26 and 52 weeks
Postoperative pain (NRS) while in hospital
Pain at mobilization (NRS) at discharge
Timed Up and Go (Tug) test
Timed Up and Go (Tug) test
Timed Up and Go (Tug) test
Timed Up and Go (Tug) test
Timed Up and Go (Tug) test
Pain (NRS)
Maximum hip pain during the last week
Pain (NRS)
Maximum hip pain during the last week
Pain (NRS)
Maximum hip pain during the last week
Pain (NRS)
Maximum hip pain during the last week
Pain (NRS)
Maximum hip pain during the last week
Satisfaction with operated hip (NRS)
Satisfaction with operated hip (NRS)
Satisfaction with operated hip (NRS)
Satisfaction with operated hip (NRS)
Satisfaction with operated hip (NRS)
Motion during healing as measured by radiostereometry.
Will be measured by RSA postoperatively, before discharge and after 4, 8, 12, 24 and 52 weeks. Pattern and time of secondary displacement will be compared between the treatment groups during the first year postoperatively.
Motion during healing as measured by plain radiographs.,
The rate and degree of secondary displacement during the first year will be compared between the groups.

Full Information

First Posted
November 12, 2014
Last Updated
September 26, 2020
Sponsor
Oslo University Hospital
Collaborators
Diakonhjemmet Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02294747
Brief Title
Trochanteric Hip Fractures (AO A2) SHS With or Without Trochanteric Stabilizing Plate - Rct Using RSA
Official Title
Trochanteric Hip Fractures (AO A2) Treated With Sliding Hip Screw With or Without Trochanteric Stabilizing Plate - a Randomized Controlled Trial Using Radiostereometry.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Diakonhjemmet Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Trochanteric fractures represent about half of the hip fractures (with femoral neck fractures as the other half). Trochanteric hip fractures are almost always treated surgically with internal fixation of the fracture. However there is a debate ongoing for what is the appropriate implant to use. For stable fracture patterns the evidence seems to be in favor of the sliding hip screw, but for the unstable fractures it is more unclear whether to use a intramedullary nail or sliding hip screw with or without a lateral support plate (TSP). The role of the TSP in clinical use remains unclear and very little has been published about this, but it is believed to be an important contributor of stability to the sliding hip screw construct. We are planning a randomized controlled trial on trochanteric hip fractures to establish a method for implanting the tantalum markers, to observe the fracture healing process and to further investigate the role of the TSP.
Detailed Description
Trochanteric fractures represent about half of the hip fractures (with femoral neck fractures as the other half), and are almost always treated surgically with internal fixation of the fracture. However, there is an ongoing debate on what is the appropriate implant to use. For stable fracture patterns the evidence seems to be in favour of the sliding hip screw, whereas for the unstable fractures it is unclear whether an intramedullary nail or a sliding hip screw with or without a lateral support plate should be the implant of choice. A series of studies is now planned at Oslo University Hospital in collaboration with Diakonhjemmet Hospital in hope to further clarify this debate. The use of the lateral/trochanteric support plate (TSP) is widespread in some regions (e.g. Norway, Sweden and parts of Britain), but virtually never used other places. The role of the TSP remains unclear and very little has been published on it's use, even though it is believed to be an important contributor of stability to the sliding hip screw construct. Trochanteric fractures are mainly caused by a direct trauma, i.e mainly a fall from own height in the elderly. The fractures are most often classified using the Müller AO classification or the Evans/Jensen, but several other classification systems also exist. The ideal classification system should be easily applicable, reliable, and aid in treatment decision making. The treatment of trochanteric fractures comprise perioperative and operative modalities. The perioperative modalities consist among others of medical optimalization preoperatively, early rehabilitation and prevention of new fractures by treating osteoporosis and preventing new falls. The main scope of the current study will, however, be the operative modalities. Surgery for trochanteric fractures is performed mainly with fracture reduction on a traction table and internal fixation, using either an intramedullary (IM) nail or a sliding hip screw (SHS), both available in various designs from different manufacturers. The latest Cochrane review did not conclude on which implant is the superior. However, among stable fractures there are less reoperations with the SHS, mainly due to peri-implant femoral fractures after operation with an IM nail that. The more unstable fractures, namely the reverse oblique and subtrochanteric fractures, may obtain better results using an intramedullary nail, probably due to less secondary dislocations with resulting varus deformity, shaft-medialization and shortening. The evidence for this is, however, weak and the role of the TSP remains unclear. Radiostereometry (RSA) is the most precise and accurate method to measure motion in vivo between different segments in orthopaedic research. To do so, radio-opaque tantalum markers are implanted into the bone defining different segments. Stereoradiographs are performed over time to detect movement and monitor the healing (or non healing) process. This movement can be calculated both as translations and rotations. They are ideal to describe and compare the stability of fracture systems. RSA has been used successfully in earlier studies on fracture healing. Due to the high accuracy and precision, RSA yield reliable results with relatively small study-groups. We plan to use RSA to measure fracture dislocation and time to healing in our studies. The study will be on the function of the trochanteric support plate and it´s ability to prevent secondary dislocation in AO 31 A2 fractures. We will utilize RSA for measurements during follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Trochanteric Fractures, Intertrochanteric Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHS without TSP
Arm Type
Active Comparator
Arm Description
Patients with AO 31 A2 trochanteric fractures operated with sliding hip screw without trochanteric stabilization plate.
Arm Title
SHS with TSP
Arm Type
Active Comparator
Arm Description
Patients with AO 31 A2 trochanteric fractures operated with sliding hip screw with trochanteric stabilization plate.
Intervention Type
Device
Intervention Name(s)
Sliding Hip Screw with Trochanteric Stabilization Plate
Other Intervention Name(s)
Lateral Stabilizing Plate, Lateral Support Shield
Intervention Type
Device
Intervention Name(s)
Sliding Hip Screw without Trochanteric Stabilization Plate
Primary Outcome Measure Information:
Title
Fracture displacement during healing measured with radiostereometry
Description
Will be measured by RSA postoperatively, before discharge and after 4, 8, 12, 24 and 52 weeks. Total displacement from first reading to the reading showing maximum displacement is the main outcome.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Perioperative blood loss
Time Frame
1 week
Title
Time of surgery
Time Frame
1 week
Title
Eq5d
Description
Health Related Quality of Life (Hrqol).
Time Frame
52 weeks
Title
Eq5d
Description
Hrqol.
Time Frame
26 weeks
Title
Eq5d
Description
Hrqol.
Time Frame
12 weeks
Title
Eq5d
Description
Hrqol.
Time Frame
8 weeks
Title
Eq5d
Description
Hrqol.
Time Frame
4 weeks
Title
Time to union as measured by RSA (cessation of motion) and radiographs
Description
When RSA shows that no motion has happened between two time points the fracture will be regarded as healed at the former time point.
Time Frame
Will be examined at 4, 8, 12, 26 and 52 weeks
Title
Time to union as measured by plain radiographs and clinical findings
Description
Composite endpoint: Healing defined by obliteration of fracture line radiographically and pain free weight bearing (except lateral pain from hardware), when this occurs the fracture will be considered healed.
Time Frame
Will be examined at 4, 8, 12, 26 and 52 weeks
Title
Harris Hip Score
Description
Will be examined at 4, 8, 12, 26 and 52 weeks
Time Frame
52 weeks
Title
Harris Hip Score
Description
Will be examined at 4, 8, 12, 26 and 52 weeks
Time Frame
26 weeks
Title
Harris Hip Score
Description
Will be examined at 4, 8, 12, 26 and 52 weeks
Time Frame
12 weeks
Title
Harris Hip Score
Description
Will be examined at 4, 8, 12, 26 and 52 weeks
Time Frame
8 weeks
Title
Harris Hip Score
Description
Will be examined at 4, 8, 12, 26 and 52 weeks
Time Frame
4 weeks
Title
Postoperative pain (NRS) while in hospital
Description
Pain at mobilization (NRS) at discharge
Time Frame
1 week
Title
Timed Up and Go (Tug) test
Time Frame
4 weeks
Title
Timed Up and Go (Tug) test
Time Frame
8 weeks
Title
Timed Up and Go (Tug) test
Time Frame
12 weeks
Title
Timed Up and Go (Tug) test
Time Frame
26 weeks
Title
Timed Up and Go (Tug) test
Time Frame
52 weeks
Title
Pain (NRS)
Description
Maximum hip pain during the last week
Time Frame
4 weeks
Title
Pain (NRS)
Description
Maximum hip pain during the last week
Time Frame
8 weeks
Title
Pain (NRS)
Description
Maximum hip pain during the last week
Time Frame
12 weeks
Title
Pain (NRS)
Description
Maximum hip pain during the last week
Time Frame
26 weeks
Title
Pain (NRS)
Description
Maximum hip pain during the last week
Time Frame
52 weeks
Title
Satisfaction with operated hip (NRS)
Time Frame
4 weeks
Title
Satisfaction with operated hip (NRS)
Time Frame
8 weeks
Title
Satisfaction with operated hip (NRS)
Time Frame
12 weeks
Title
Satisfaction with operated hip (NRS)
Time Frame
26 weeks
Title
Satisfaction with operated hip (NRS)
Time Frame
52 weeks
Title
Motion during healing as measured by radiostereometry.
Description
Will be measured by RSA postoperatively, before discharge and after 4, 8, 12, 24 and 52 weeks. Pattern and time of secondary displacement will be compared between the treatment groups during the first year postoperatively.
Time Frame
52 weeks
Title
Motion during healing as measured by plain radiographs.,
Description
The rate and degree of secondary displacement during the first year will be compared between the groups.
Time Frame
52 weeks
Other Pre-specified Outcome Measures:
Title
Reoperation for healing problems
Description
Any additional surgery addressing healing problems or hardware failure
Time Frame
52 weeks
Title
Mortality
Description
Any reason
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AO 31-A2 able to walk independently, aids such as crutches or walker allowed able to consent fit for surgery with SHS with or without TSP Exclusion Criteria: not willing or able to attain follow up previous fracture or surgery with retained metal work in the same hip concomitant disease that will shorten life expectancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frede Frihagen, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Center, Ulleval University Hospital
City
Oslo
ZIP/Postal Code
0408
Country
Norway
Facility Name
Diakonhjemmet Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Trochanteric Hip Fractures (AO A2) SHS With or Without Trochanteric Stabilizing Plate - Rct Using RSA

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