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Completed

NCT Number: NCT02699619

Undisplaced Femoral Neck Fractures 2 Hansson Pins or 3 Pins Interlocked in Plate (Pinloc) Using RSA

Femoral neck fractures represent about half of the hip fractures and are further divided into displaced and undisplaced fractures. Displaced femoral neck fractures are almost always treated surgically with arthroplasty. However there is an ongoing debate on which implant is superior for undisplaced fractures.

A novel implant design (Pinloc) has been developed by Swemac Innovation AB. While the original implant consisted of 2 isolated hook pins, the modified design consists of 3 titanium hook pins interlocked in an aluminum plate. Interlocking is a new principle of implant design and improves fixation and load transfer amongst the pins. The superiority of the modified design is so far only proven preclinically.

The role of the Pinloc in clinical use remains unclear. Investigators are planning a randomized controlled trial on undisplaced femoral neck fractures to establish a method for implanting the tantalum markers, to observe the fracture healing process and to further investigate the role of the Pinloc.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedic Center, Ulleval University Hospital

Oslo, 0408, Norway

About this study

Femoral neck fractures represent about half of the hip fractures and are further divided into displaced and undisplaced fractures. Displaced femoral neck fractures are almost always treated surgically with arthroplasty. However there is an ongoing debate on which implant is superior for undisplaced fractures.

A novel implant design (Pinloc) has been developed by Swemac Innovation AB. While the original implant consisted of 2 isolated hook pins, the modified design consists of 3 titanium hook pins interlocked in an aluminum plate. Interlocking is a new principle of implant design and improves fixation and load transfer amongst the pins. The superiority of the modified design is so far only proven preclinically. The role of the Pinloc in clinical use remains unclear.

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 Pinloc has been introduced in some regions (e.g. Norway, Sweden and Japan). The role of the Pinloc 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 fixation.

Femoral neck fractures are mainly caused by a fall from own height in the elderly. The fractures are most often classified as displaced or not, using the simplified Garden classification. Several other classification systems also exist, but these have not been shown to be of reliable clinical usefulness. The ideal classification system should be easily applicable, reliable, and aid in treatment decision making and prognosis.

The treatment of femoral neck 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 undsiplaced femoral neck fractures is performed mainly with internal fixation on a traction table, using either screws, pins or a sliding hip screw (SHS), available in various designs from different manufacturers. The latest Cochrane review did not conclude on which implant is the superior.

Radiostereometry (RSA) is the most precise and accurate method to measure motion in vivo between different segments in orthopaedic research. To do so, radioopaque 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. Investigators plan to use RSA to measure fracture dislocation and time to healing in our studies. The study will be on the function of the Pinloc and it´s ability to prevent secondary dislocation in undisplaced femoral neck fractures. Investigators will utilize RSA for measurements during follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undisplaced femoral neck fractures
  • able to walk independently, aids such as crutches or walker allowed
  • able to consent
  • fit for surgery with pins with or without plate

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 (i.e. cancer, COPD)

Treatment and study plan

Pinloc

Device

3 hook pins interlocked in plate.

Other names: 3 hook pins interlocked in plate.

2 Hansson pins

Device

2 isolated hook pins.(Without plate)

Other names: 2 isolated hook pins.

Primary outcomes

  1. Change in fracture displacement during healing measured with radiostereometry

    Time frame: Up to 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.

Secondary outcomes

  1. Perioperative blood loss

    Time frame: 1 week

  2. Time of surgery

    Time frame: 1 week

  3. Eq5d

    Time frame: 52 weeks

    Health Related Quality of Life (Hrqol).

  4. Eq5d

    Time frame: 26 weeks

    Hrqol.

  5. Eq5d

    Time frame: 12 weeks

    Hrqol.

  6. Eq5d

    Time frame: 4 weeks

    Hrqol.

  7. Change in time to union as measured by RSA (cessation of motion) and radiographs

    Time frame: Will be examined at 4, 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.

  8. Change in time to union as measured by plain radiographs and clinical findings

    Time frame: Will be examined at 4,12, 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.

  9. Harris Hip Score

    Time frame: Up to 52 weeks

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

  10. Postoperative pain (NRS) while in hospital

    Time frame: 1 week

    Pain at mobilization (NRS) at discharge

  11. Timed Up and Go test

    Time frame: 4 weeks

    Tug

  12. Timed Up and Go test

    Time frame: 12 weeks

    Tug

  13. Timed Up and Go test

    Time frame: 26 weeks

    Tug

  14. Timed Up and Go test

    Time frame: 52 weeks

    Tug

  15. Pain (NRS)

    Time frame: 4 weeks

    Maximum hip pain during the last week

  16. Pain (NRS)

    Time frame: 12 weeks

    Maximum hip pain during the last week

  17. Pain (NRS)

    Time frame: 26 weeks

    Maximum hip pain during the last week

  18. Pain (NRS)

    Time frame: 52 weeks

    Maximum hip pain during the last week

  19. Satisfaction with operated hip (NRS)

    Time frame: 4 weeks

    NRS

  20. Satisfaction with operated hip (NRS)

    Time frame: 12 weeks

    NRS

  21. Satisfaction with operated hip (NRS)

    Time frame: 26 weeks

    NRS

  22. Satisfaction with operated hip (NRS)

    Time frame: 52 weeks

    NRS

  23. Motion during healing as measured by radiostereometry.

    Time frame: Up to 52 weeks

    Will be measured by RSA postoperatively, before discharge and after 4, 12, 24 and 52 weeks.

  24. Motion during healing as measured by plain radiographs.

    Time frame: Up to 52 weeks

    Will be measured by RSA postoperatively, before discharge and after 4,12, 24 and 52 weeks.

  25. Reoperation for healing problems

    Time frame: 52 weeks

    Any additional surgery addressing healing problems or hardware failure

  26. Mortality

    Time frame: 52 weeks

    Any reason

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Diakonhjemmet Hospital

Registry information

Official study title

Undisplaced Femoral Neck Fractures Treated With 2 Hansson Pins Without Plate or 3 Hansson Pins Interlocked in a Plate (Pinloc) - A Randomized Controlled Trial Using Radiostereometry

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2016
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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