Hip FracturesNCT02294747
Trochanteric Hip Fractures (AO A2) SHS With or Without Trochanteric Stabilizing Plate - Rct Using RSA
A study testing Sliding Hip Screw with Trochanteric Stabilization Plate and Sliding Hip Screw without Trochanteric Stabilization Plate in people with Hip Fractures and Trochanteric Fractures, run by Oslo University Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fractures, Trochanteric Fractures, Intertrochanteric Fractures
- What is being tested?
- Sliding Hip Screw with Trochanteric Stabilization Plate and Sliding Hip Screw without Trochanteric Stabilization Plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesNorway
- Study dates
- Nov 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Orthopedic Center, Ulleval University Hospital
Oslo, 0408
Diakonhjemmet Hospital
Oslo
About this study
Official title: Trochanteric Hip Fractures (AO A2) Treated With Sliding Hip Screw With or Without Trochanteric Stabilizing Plate - a Randomized Controlled Trial Using Radiostereometry.
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.
Read the 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.
- Being tested
- Sliding Hip Screw with Trochanteric Stabilization Plate, Sliding Hip Screw without Trochanteric Stabilization Plate
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sliding Hip Screw with Trochanteric Stabilization PlateDevice
Also called Lateral Stabilizing Plate, Lateral Support Shield
Sliding Hip Screw without Trochanteric Stabilization PlateDevice
| Study group | Role | What they receive |
|---|---|---|
| SHS without TSP | Active comparator | Patients with AO 31 A2 trochanteric fractures operated with sliding hip screw without trochanteric stabilization plate. Receives: Device: Sliding Hip Screw without Trochanteric Stabilization Plate |
| SHS with TSP | Active comparator | Patients with AO 31 A2 trochanteric fractures operated with sliding hip screw with trochanteric stabilization plate. Receives: Device: Sliding Hip Screw with Trochanteric Stabilization Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks
Secondary outcomes (32)
Perioperative blood loss
Measured: 1 week
Time of surgery
Measured: 1 week
Eq5d
Health Related Quality of Life (Hrqol).
Measured: 52 weeks
Eq5d
Hrqol.
Measured: 26 weeks
Eq5d
Hrqol.
Measured: 12 weeks
Eq5d
Hrqol.
Measured: 8 weeks
Eq5d
Hrqol.
Measured: 4 weeks
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.
Measured: Will be examined at 4, 8, 12, 26 and 52 weeks
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.
Measured: 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
Measured: 52 weeks
Harris Hip Score
Will be examined at 4, 8, 12, 26 and 52 weeks
Measured: 26 weeks
Harris Hip Score
Will be examined at 4, 8, 12, 26 and 52 weeks
Measured: 12 weeks
Harris Hip Score
Will be examined at 4, 8, 12, 26 and 52 weeks
Measured: 8 weeks
Harris Hip Score
Will be examined at 4, 8, 12, 26 and 52 weeks
Measured: 4 weeks
Postoperative pain (NRS) while in hospital
Pain at mobilization (NRS) at discharge
Measured: 1 week
Timed Up and Go (Tug) test
Measured: 4 weeks
Timed Up and Go (Tug) test
Measured: 8 weeks
Timed Up and Go (Tug) test
Measured: 12 weeks
Timed Up and Go (Tug) test
Measured: 26 weeks
Timed Up and Go (Tug) test
Measured: 52 weeks
Pain (NRS)
Maximum hip pain during the last week
Measured: 4 weeks
Pain (NRS)
Maximum hip pain during the last week
Measured: 8 weeks
Pain (NRS)
Maximum hip pain during the last week
Measured: 12 weeks
Pain (NRS)
Maximum hip pain during the last week
Measured: 26 weeks
Pain (NRS)
Maximum hip pain during the last week
Measured: 52 weeks
Satisfaction with operated hip (NRS)
Measured: 4 weeks
Satisfaction with operated hip (NRS)
Measured: 8 weeks
Satisfaction with operated hip (NRS)
Measured: 12 weeks
Satisfaction with operated hip (NRS)
Measured: 26 weeks
Satisfaction with operated hip (NRS)
Measured: 52 weeks
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.
Measured: 52 weeks
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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Diakonhjemmet Hospital
- Responsible party
- Principal investigator, Frede Frihagen, Oslo University Hospital
- Investigators
- Frede Frihagen, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294747
- Sponsor's protocol ID
- 2014/475/REK SO B
- Status last verified
- Sep 2020
- First submitted
- 12 Nov 2014
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trochanteric Hip Fractures (AO A2) Treated With Sliding Hip Screw With or Without Trochanteric Stabilizing Plate - a Randomized Controlled Trial Using Radiostereometry.
- ClinicalTrials.gov ID
- NCT02294747
- Acronym / sponsor ID
- 2014/475/REK SO B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Diakonhjemmet Hospital
- Study start
- Nov 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHS without TSP | Active comparator | Device: Sliding Hip Screw without Trochanteric Stabilization PlatePatients with AO 31 A2 trochanteric fractures operated with sliding hip screw without trochanteric stabilization plate. |
| SHS with TSP | Active comparator | Device: Sliding Hip Screw with Trochanteric Stabilization PlatePatients with AO 31 A2 trochanteric fractures operated with sliding hip screw with trochanteric stabilization plate. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sliding Hip Screw with Trochanteric Stabilization PlateAlso: Lateral Stabilizing Plate, Lateral Support Shield | Device | SHS with TSP |
| Sliding Hip Screw without Trochanteric Stabilization Plate | Device | SHS without TSP |
Primary outcome
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.
32 secondary outcomes
Perioperative blood loss
Time frame: 1 week
Time of surgery
Time frame: 1 week
Eq5d
Time frame: 52 weeks
Eq5d
Time frame: 26 weeks
Eq5d
Time frame: 12 weeks
Eq5d
Time frame: 8 weeks
Eq5d
Time frame: 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
Time to union as measured by plain radiographs and clinical findings
Time frame: Will be examined at 4, 8, 12, 26 and 52 weeks
Harris Hip Score
Time frame: 52 weeks
Harris Hip Score
Time frame: 26 weeks
Harris Hip Score
Time frame: 12 weeks
Harris Hip Score
Time frame: 8 weeks
Harris Hip Score
Time frame: 4 weeks
Postoperative pain (NRS) while in hospital
Time frame: 1 week
Timed Up and Go (Tug) test
Time frame: 4 weeks
Timed Up and Go (Tug) test
Time frame: 8 weeks
Timed Up and Go (Tug) test
Time frame: 12 weeks
Timed Up and Go (Tug) test
Time frame: 26 weeks
Timed Up and Go (Tug) test
Time frame: 52 weeks
Pain (NRS)
Time frame: 4 weeks
Pain (NRS)
Time frame: 8 weeks
Pain (NRS)
Time frame: 12 weeks
Pain (NRS)
Time frame: 26 weeks
Pain (NRS)
Time frame: 52 weeks
Satisfaction with operated hip (NRS)
Time frame: 4 weeks
Satisfaction with operated hip (NRS)
Time frame: 8 weeks
Satisfaction with operated hip (NRS)
Time frame: 12 weeks
Satisfaction with operated hip (NRS)
Time frame: 26 weeks
Satisfaction with operated hip (NRS)
Time frame: 52 weeks
Motion during healing as measured by radiostereometry.
Time frame: 52 weeks
Motion during healing as measured by plain radiographs.,
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frede Frihagen, PhD principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sliding Hip Screw with Trochanteric Stabilization Plate and Sliding Hip Screw without Trochanteric Stabilization Plate in people with Hip Fractures and Trochanteric Fractures, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture displacement during healing measured with radiostereometry (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.