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

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ClinicalTrials.gov Identifier: NCT02699619
Recruitment Status : Active, not recruiting
First Posted : March 4, 2016
Last Update Posted : September 28, 2020
Sponsor:
Collaborator:
Diakonhjemmet Hospital
Information provided by (Responsible Party):
Frede Frihagen, Oslo University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hip Fractures Femoral Neck Fractures Device: Pinloc Device: 2 Hansson pins Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 2 Hansson pins without plate
Patients with undisplaced femoral neck fractures operated with 2 isolated Hansson pins.
Device: 2 Hansson pins
2 isolated hook pins.(Without plate)
Other Name: 2 isolated hook pins.

Active Comparator: 3 Hansson pins interlocked in a plate
Patients with undisplaced femoral neck fractures operated with 3 Hansson pins interlocked in plate (Pinloc).
Device: Pinloc
3 hook pins interlocked in plate.
Other Name: 3 hook pins interlocked in plate.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699619


Locations
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Norway
Orthopedic Center, Ulleval University Hospital
Oslo, Norway, 0408
Sponsors and Collaborators
Oslo University Hospital
Diakonhjemmet Hospital
Investigators
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Principal Investigator: Frede Frihagen, PhD Oslo UH
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Responsible Party: Frede Frihagen, Consultant, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02699619    
Other Study ID Numbers: 2015/191/REK SO B
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: International peer review journal
Keywords provided by Frede Frihagen, Oslo University Hospital:
Undisplaced
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Femoral Neck Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries