- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02294747
Trochanteric Hip Fractures (AO A2) SHS With or Without Trochanteric Stabilizing Plate - Rct Using RSA
Trochanteric Hip Fractures (AO A2) Treated With Sliding Hip Screw With or Without Trochanteric Stabilizing Plate - a Randomized Controlled Trial Using Radiostereometry.
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0408
- Orthopedic Center, Ulleval University Hospital
-
Oslo, Norway
- Diakonhjemmet Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SHS without TSP
Patients with AO 31 A2 trochanteric fractures operated with sliding hip screw without trochanteric stabilization plate.
|
|
Active Comparator: SHS with TSP
Patients with AO 31 A2 trochanteric fractures operated with sliding hip screw with trochanteric stabilization plate.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fracture displacement during healing measured with radiostereometry
Time Frame: 52 weeks
|
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.
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perioperative blood loss
Time Frame: 1 week
|
1 week
|
|
Time of surgery
Time Frame: 1 week
|
1 week
|
|
Eq5d
Time Frame: 52 weeks
|
Health Related Quality of Life (Hrqol).
|
52 weeks
|
Eq5d
Time Frame: 26 weeks
|
Hrqol.
|
26 weeks
|
Eq5d
Time Frame: 12 weeks
|
Hrqol.
|
12 weeks
|
Eq5d
Time Frame: 8 weeks
|
Hrqol.
|
8 weeks
|
Eq5d
Time Frame: 4 weeks
|
Hrqol.
|
4 weeks
|
Time to union as measured by RSA (cessation of motion) and radiographs
Time Frame: Will be examined at 4, 8, 12, 26 and 52 weeks
|
When RSA shows that no motion has happened between two time points the fracture will be regarded as healed at the former time point.
|
Will be examined at 4, 8, 12, 26 and 52 weeks
|
Time to union as measured by plain radiographs and clinical findings
Time Frame: Will be examined at 4, 8, 12, 26 and 52 weeks
|
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.
|
Will be examined at 4, 8, 12, 26 and 52 weeks
|
Harris Hip Score
Time Frame: 52 weeks
|
Will be examined at 4, 8, 12, 26 and 52 weeks
|
52 weeks
|
Harris Hip Score
Time Frame: 26 weeks
|
Will be examined at 4, 8, 12, 26 and 52 weeks
|
26 weeks
|
Harris Hip Score
Time Frame: 12 weeks
|
Will be examined at 4, 8, 12, 26 and 52 weeks
|
12 weeks
|
Harris Hip Score
Time Frame: 8 weeks
|
Will be examined at 4, 8, 12, 26 and 52 weeks
|
8 weeks
|
Harris Hip Score
Time Frame: 4 weeks
|
Will be examined at 4, 8, 12, 26 and 52 weeks
|
4 weeks
|
Postoperative pain (NRS) while in hospital
Time Frame: 1 week
|
Pain at mobilization (NRS) at discharge
|
1 week
|
Timed Up and Go (Tug) test
Time Frame: 4 weeks
|
4 weeks
|
|
Timed Up and Go (Tug) test
Time Frame: 8 weeks
|
8 weeks
|
|
Timed Up and Go (Tug) test
Time Frame: 12 weeks
|
12 weeks
|
|
Timed Up and Go (Tug) test
Time Frame: 26 weeks
|
26 weeks
|
|
Timed Up and Go (Tug) test
Time Frame: 52 weeks
|
52 weeks
|
|
Pain (NRS)
Time Frame: 4 weeks
|
Maximum hip pain during the last week
|
4 weeks
|
Pain (NRS)
Time Frame: 8 weeks
|
Maximum hip pain during the last week
|
8 weeks
|
Pain (NRS)
Time Frame: 12 weeks
|
Maximum hip pain during the last week
|
12 weeks
|
Pain (NRS)
Time Frame: 26 weeks
|
Maximum hip pain during the last week
|
26 weeks
|
Pain (NRS)
Time Frame: 52 weeks
|
Maximum hip pain during the last week
|
52 weeks
|
Satisfaction with operated hip (NRS)
Time Frame: 4 weeks
|
4 weeks
|
|
Satisfaction with operated hip (NRS)
Time Frame: 8 weeks
|
8 weeks
|
|
Satisfaction with operated hip (NRS)
Time Frame: 12 weeks
|
12 weeks
|
|
Satisfaction with operated hip (NRS)
Time Frame: 26 weeks
|
26 weeks
|
|
Satisfaction with operated hip (NRS)
Time Frame: 52 weeks
|
52 weeks
|
|
Motion during healing as measured by radiostereometry.
Time Frame: 52 weeks
|
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.
|
52 weeks
|
Motion during healing as measured by plain radiographs.,
Time Frame: 52 weeks
|
The rate and degree of secondary displacement during the first year will be compared between the groups.
|
52 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reoperation for healing problems
Time Frame: 52 weeks
|
Any additional surgery addressing healing problems or hardware failure
|
52 weeks
|
Mortality
Time Frame: 52 weeks
|
Any reason
|
52 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frede Frihagen, PhD, Oslo University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/475/REK SO B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fractures
-
Smith & Nephew, Inc.Terminated
-
Texas Tech University Health Sciences Center, El...CompletedHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)United States
-
FH ORTHORecruitingHip Fractures | Hip DiseaseFrance
-
Zhenjiang First People's HospitalCompletedHip Fractures | Hip DiseaseChina
-
Bayside HealthCompleted
-
Carilion ClinicCompleted
-
University of Missouri-ColumbiaUniversity of Alabama at Birmingham; Medical College of Wisconsin; University...CompletedHip Fractures | Pelvic Fractures | Acetabular FracturesUnited States
-
Rabin Medical CenterUnknown
-
Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
-
Pacira Pharmaceuticals, IncWithdrawnHip Fractures | Intertrochanteric FracturesUnited States
Clinical Trials on Sliding Hip Screw without Trochanteric Stabilization Plate
-
Stryker Trauma GmbHGlobal Research Solutions; Stryker OsteosynthesisCompletedFemoral Neck Fractures | Intertrochanteric FractureSweden, Denmark, Canada
-
Rudy ReindlOrthopaedic Trauma AssociationCompleted
-
Stryker Trauma GmbHGlobal Research SolutionsCompletedFemoral Neck Fractures | Intertrochanteric FractureUnited States, United Kingdom, Canada, Denmark, Germany, Australia, China, Colombia, Japan, Netherlands, Norway, South Africa
-
Peterborough and Stamford Hospitals NHS Foundation...Completed
-
University Hospital WaterfordDePuy SynthesRecruitingHip Fractures | Gait, Unsteady | FunctionIreland
-
Lawson Health Research InstituteOrthopaedic Research FoundationCompleted
-
The Fuzhou No 2 HospitalCompletedFemoral Neck Fractures
-
Ibn Jazzar HospitalCompletedProximal Femur FracturesTunisia
-
University of AarhusHvidovre University Hospital; Hospitalsenheden VestCompletedIntertrochanteric Fractures
-
Smith & Nephew Orthopaedics AGTerminated