Hip FracturesNCT02699619
Undisplaced Femoral Neck Fractures 2 Hansson Pins or 3 Pins Interlocked in Plate (Pinloc) Using RSA
A study testing Pinloc and 2 Hansson pins in people with Hip Fractures and Femoral Neck Fractures, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures, Femoral Neck Fractures
- What is being tested?
- Pinloc and 2 Hansson pins
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2016to May 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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 (i.e. cancer, COPD)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hip Fractures, Femoral Neck Fractures
- Being tested
- Pinloc, 2 Hansson pins
- Keywords
- Undisplaced
- Medical subject headings
- Hip Fractures, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PinlocDevice
Also called 3 hook pins interlocked in plate.
3 hook pins interlocked in plate.
2 Hansson pinsDevice
Also called 2 isolated hook pins.
2 isolated hook pins.(Without plate)
| Study group | Role | What they receive |
|---|---|---|
| 2 Hansson pins without plate | Active comparator | Patients with undisplaced femoral neck fractures operated with 2 isolated Hansson pins. Receives: Device: 2 Hansson pins |
| 3 Hansson pins interlocked in a plate | Active comparator | Patients with undisplaced femoral neck fractures operated with 3 Hansson pins interlocked in plate (Pinloc). Receives: Device: Pinloc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 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: Up to 52 weeks
Secondary outcomes (26)
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: 4 weeks
Change in 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, 12, 26 and 52 weeks
Change in 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 4,12, 26 and 52 weeks
Harris Hip Score
Will be examined at 4,12, 26 and 52 weeks
Measured: Up to 52 weeks
Postoperative pain (NRS) while in hospital
Pain at mobilization (NRS) at discharge
Measured: 1 week
Timed Up and Go test
Tug
Measured: 4 weeks
Timed Up and Go test
Tug
Measured: 12 weeks
Timed Up and Go test
Tug
Measured: 26 weeks
Timed Up and Go test
Tug
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: 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)
NRS
Measured: 4 weeks
Satisfaction with operated hip (NRS)
NRS
Measured: 12 weeks
Satisfaction with operated hip (NRS)
NRS
Measured: 26 weeks
Satisfaction with operated hip (NRS)
NRS
Measured: 52 weeks
Motion during healing as measured by radiostereometry.
Will be measured by RSA postoperatively, before discharge and after 4, 12, 24 and 52 weeks.
Measured: Up to 52 weeks
Motion during healing as measured by plain radiographs.
Will be measured by RSA postoperatively, before discharge and after 4,12, 24 and 52 weeks.
Measured: Up to 52 weeks
Reoperation for healing problems
Any additional surgery addressing healing problems or hardware failure
Measured: 52 weeks
Mortality
Any reason
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 posted4 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2021
- Study completionMay 2021
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
- None (open label)
- Enrolment
- 26 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 UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699619
- Sponsor's protocol ID
- 2015/191/REK SO B
- Status last verified
- May 2021
- First submitted
- 20 Jan 2016
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: International peer review journal
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02699619
- Acronym / sponsor ID
- 2015/191/REK SO B
- Conditions
- Hip Fractures, Femoral Neck Fractures
- Keywords
- Undisplaced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Diakonhjemmet Hospital
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 4 Mar 2016 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 Hansson pins without plate | Active comparator | Device: 2 Hansson pinsPatients with undisplaced femoral neck fractures operated with 2 isolated Hansson pins. |
| 3 Hansson pins interlocked in a plate | Active comparator | Device: PinlocPatients with undisplaced femoral neck fractures operated with 3 Hansson pins interlocked in plate (Pinloc). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
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 (i.e. cancer, COPD)
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 |
|---|---|---|
| PinlocAlso: 3 hook pins interlocked in plate.3 hook pins interlocked in plate. | Device | 3 Hansson pins interlocked in a plate |
| 2 Hansson pinsAlso: 2 isolated hook pins.2 isolated hook pins.(Without plate) | Device | 2 Hansson pins without plate |
Primary outcome
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.
26 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: 4 weeks
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
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
Harris Hip Score
Time frame: Up to 52 weeks
Postoperative pain (NRS) while in hospital
Time frame: 1 week
Timed Up and Go test
Time frame: 4 weeks
Timed Up and Go test
Time frame: 12 weeks
Timed Up and Go test
Time frame: 26 weeks
Timed Up and Go test
Time frame: 52 weeks
Pain (NRS)
Time frame: 4 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: 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: Up to 52 weeks
Motion during healing as measured by plain radiographs.
Time frame: Up to 52 weeks
Reoperation for healing problems
Time frame: 52 weeks
Mortality
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 11 May 2021.
- Individual participant dataSharing planned: Yes. International peer review journal
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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 UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pinloc and 2 Hansson pins in people with Hip Fractures and Femoral Neck Fractures, run by Oslo University Hospital at 1 site 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in fracture displacement during healing measured with radiostereometry (time frame: Up to 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 11 May 2021.