Femoral Neck FracturesNCT02776631
Pinloc Versus Hansson Pins in the Treatment of Femoral Neck Fractures.
A study testing Pinloc and Hansson Pins (LIH) in people with Femoral Neck Fractures, run by Torsten Johansson at 8 sites in Sweden.
Trial summary
A prospective randomized study comparing a new implant with three interlocked pins for internal fixation of femoral neck fractures (Hansson Pinloc System, Swemac Linköping, Sweden) versus 2 parallel pins with hooks (Hansson Pins, Swemac Linköping, Sweden). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Pinloc and Hansson Pins (LIH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 537 participants
- Where
- 8 sitesSweden
- Study dates
- May 2014to Dec 2019
- 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
- Femoral neck fractures where the preferred treatment is internal fixation.
Who cannot join
- Unwilling to participate.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Sweden8 sites
Department of Orthopedics
Eskilstuna, 631 88
Department of Orthopedics
Falun, 791 82
Department of Orthopaedics
Gothenburg, 413 45
Department of Orthopedics
Helsingborg, 251 87
Department of Orthopedics, Aleris
Motala, 591 85
Department of Orthopedics
Norrköping, 601 82
Department of Orthopedics
Nyköping, 611 88
Department of Orthopedics
Uppsala, 751 85
About this study
Official title: Pinloc Versus Hansson Pins in the Treatment of Femoral Neck Fractures: A Prospective Randomized Study of 500 Patients
A prospective randomized study comparing a new implant with three interlocked pins for internal fixation of femoral neck fractures (Hansson Pinloc System, Swemac Linköping, Sweden) versus 2 parallel pins with hooks (Hansson Pins, Swemac Linköping, Sweden).
Read the detailed description
Patients, who are to be treated with internal fixation due to a femoral neck fracture, will be randomized by the surgeon to Pinloc or Hansson Pins using an on-line randomization system.
The patients will be followed up at open visits at 3 months and 1 year. At two years the patients will be contacted by phone and medical records studied in order to detect any fracture complications.
- Conditions
- Femoral Neck Fractures
- Being tested
- Pinloc, Hansson Pins (LIH)
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PinlocDevice
Internal fixation device
Hansson Pins (LIH)Device
Internal fixation device
| Study group | Role | What they receive |
|---|---|---|
| Pinloc | Experimental | Plate and 3 interlocked pins. A new device for fixation of femoral neck fractures. Receives: Device: Pinloc |
| LIH (Hansson pins) | Active comparator | 2 pins. An established method for fixation of femoral neck fractures. Receives: Device: Hansson Pins (LIH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of fracture treatment
Failure is defined as non-union or avascular necrosis.
Measured: Within 2 years postoperatively
Secondary outcomes (4)
Timed-up and go test
Stand up, walk 3 meters, turn around and sit down
Measured: At 3 months and 1 year postoperatively
WOMAC (An established hip score)
An established hip score
Measured: At 3 months and 1 year postoperatively
Quality of life (EQ-5D)
EQ-5D
Measured: At 3 months and 1 year postoperatively
Pain (Visual analogue scale)
Visual analogue scale (VAS): At rest and during activity
Measured: At 3 months and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startMay 2014
- Primary completionFeb 2019
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- 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
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torsten Johansson
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Department of Orthopedics, Motala, Department of Orthopedics, Norrköping, Department of Orthopedics, Nykoeping, Department of Orthopedics, Eskilstuna, Department of Orthopedics, Falun, Uppsala University Hospital, Department of Orthopedics, Helsingborg
- Responsible party
- Sponsor-investigator, Torsten Johansson, University Hospital, Linkoeping
- Investigators
- Torsten Johansson, MD,Ass prof, Principal investigator, Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden.Torsten Johansson, MD,Ass prof, Study director, Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776631
- Sponsor's protocol ID
- Pinloc study
- Status last verified
- Apr 2019
- First submitted
- 20 Jan 2016
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pinloc Versus Hansson Pins in the Treatment of Femoral Neck Fractures: A Prospective Randomized Study of 500 Patients
- ClinicalTrials.gov ID
- NCT02776631
- Acronym / sponsor ID
- Pinloc study
- Conditions
- Femoral Neck Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Torsten JohanssonUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Department of Orthopedics, Motala, Department of Orthopedics, Norrköping, Department of Orthopedics, Nykoeping, Department of Orthopedics, Eskilstuna, Department of Orthopedics, Falun, Uppsala University Hospital, Department of Orthopedics, Helsingborg
- Study start
- May 2014 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 May 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.
A prospective randomized study comparing a new implant with three interlocked pins for internal fixation of femoral neck fractures (Hansson Pinloc System, Swemac Linköping, Sweden) versus 2 parallel pins with hooks (Hansson Pins, Swemac Linköping, Sweden).
Detailed description
Patients, who are to be treated with internal fixation due to a femoral neck fracture, will be randomized by the surgeon to Pinloc or Hansson Pins using an on-line randomization system.
The patients will be followed up at open visits at 3 months and 1 year. At two years the patients will be contacted by phone and medical records studied in order to detect any fracture complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pinloc | Experimental | Device: PinlocPlate and 3 interlocked pins. A new device for fixation of femoral neck fractures. |
| LIH (Hansson pins) | Active comparator | Device: Hansson Pins (LIH)2 pins. An established method for fixation of femoral neck fractures. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Femoral neck fractures where the preferred treatment is internal fixation.
Key exclusion criteria (1 listed)
- Unwilling to participate.
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 |
|---|---|---|
| PinlocInternal fixation device | Device | Pinloc |
| Hansson Pins (LIH)Internal fixation device | Device | LIH (Hansson pins) |
Primary outcome
Failure of fracture treatment
Time frame: Within 2 years postoperatively
Failure is defined as non-union or avascular necrosis.
4 secondary outcomes
Timed-up and go test
Time frame: At 3 months and 1 year postoperatively
WOMAC (An established hip score)
Time frame: At 3 months and 1 year postoperatively
Quality of life (EQ-5D)
Time frame: At 3 months and 1 year postoperatively
Pain (Visual analogue scale)
Time frame: At 3 months and 1 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Yes
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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.
Torsten Johansson, MD,Ass prof principal investigator
Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden.
Torsten Johansson, MD,Ass prof study director
Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pinloc and Hansson Pins (LIH) in people with Femoral Neck Fractures, run by Torsten Johansson at 8 sites in Sweden.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden. 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?
Results are not available in the source record.
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?
Failure of fracture treatment (time frame: Within 2 years postoperatively). 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 17 Apr 2019.