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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Norway

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 groups in NCT02294747
Study groupRoleWhat they receive
SHS without TSPActive comparatorPatients 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 TSPActive comparatorPatients 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.

  1. 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)
  1. Perioperative blood loss

    Measured: 1 week

  2. Time of surgery

    Measured: 1 week

  3. Eq5d

    Health Related Quality of Life (Hrqol).

    Measured: 52 weeks

  4. Eq5d

    Hrqol.

    Measured: 26 weeks

  5. Eq5d

    Hrqol.

    Measured: 12 weeks

  6. Eq5d

    Hrqol.

    Measured: 8 weeks

  7. Eq5d

    Hrqol.

    Measured: 4 weeks

  8. 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

  9. 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

  10. Harris Hip Score

    Will be examined at 4, 8, 12, 26 and 52 weeks

    Measured: 52 weeks

  11. Harris Hip Score

    Will be examined at 4, 8, 12, 26 and 52 weeks

    Measured: 26 weeks

  12. Harris Hip Score

    Will be examined at 4, 8, 12, 26 and 52 weeks

    Measured: 12 weeks

  13. Harris Hip Score

    Will be examined at 4, 8, 12, 26 and 52 weeks

    Measured: 8 weeks

  14. Harris Hip Score

    Will be examined at 4, 8, 12, 26 and 52 weeks

    Measured: 4 weeks

  15. Postoperative pain (NRS) while in hospital

    Pain at mobilization (NRS) at discharge

    Measured: 1 week

  16. Timed Up and Go (Tug) test

    Measured: 4 weeks

  17. Timed Up and Go (Tug) test

    Measured: 8 weeks

  18. Timed Up and Go (Tug) test

    Measured: 12 weeks

  19. Timed Up and Go (Tug) test

    Measured: 26 weeks

  20. Timed Up and Go (Tug) test

    Measured: 52 weeks

  21. Pain (NRS)

    Maximum hip pain during the last week

    Measured: 4 weeks

  22. Pain (NRS)

    Maximum hip pain during the last week

    Measured: 8 weeks

  23. Pain (NRS)

    Maximum hip pain during the last week

    Measured: 12 weeks

  24. Pain (NRS)

    Maximum hip pain during the last week

    Measured: 26 weeks

  25. Pain (NRS)

    Maximum hip pain during the last week

    Measured: 52 weeks

  26. Satisfaction with operated hip (NRS)

    Measured: 4 weeks

  27. Satisfaction with operated hip (NRS)

    Measured: 8 weeks

  28. Satisfaction with operated hip (NRS)

    Measured: 12 weeks

  29. Satisfaction with operated hip (NRS)

    Measured: 26 weeks

  30. Satisfaction with operated hip (NRS)

    Measured: 52 weeks

  31. 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

  32. 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.

  1. First posted19 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

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)
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

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.

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