Hip FracturesNCT04240743
Fixation Methods of Basicervical Fractures
A study testing cephalomedullary nail and sliding hip screw in people with Hip Fractures and Osteoporotic Fractures, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital.
Trial summary
This prospective, randomized study included patients aged over 65 years with basicervical fracture of femur from January 2016 to January 2018. The permuted block randomization method was used to randomize participants into groups. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Osteoporotic Fractures
- What is being tested?
- cephalomedullary nail and sliding hip screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jan 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- basicervical fracture,
- age of ≥65 year,
- an isolated fracture,
- the ability to walk independently (with or without an aid) prior to fracture,
- a fracture that had occurred less than one week prior to admission.
Who cannot join
- history of ipsilateral femoral fracture,
- a fracture due to malignancy,
- limited life expectancy due to medical comorbidities,
- any contraindication to surgery,
- diagnosed dementia,
- any other traumatic fracture on admission.
About this study
Official title: Comparison of Intramedullary and Extramedullary Fixation of Basicervical Fractures of the Femur in the Elderly: a Prospective, Randomized Controlled Trial
This prospective, randomized study included patients aged over 65 years with basicervical fracture of femur from January 2016 to January 2018. The permuted block randomization method was used to randomize participants into groups. The patients were allocated to one of two groups treated via cephalomedullary nail (CMN) or sliding hip screw (SHS). Functional and radiological evaluations was included the mobility score, Harris hip score, modified Barthel index, the Singh index, the tip-apex distance, and fracture settling.
Read the detailed description
Approval for this prospective randomized study was granted by the Local Ethics Review Board and all procedures were performed in accordance with the ethical standards of the Declaration of Helsinki (1964). Patients with a basicervical femur fracture were identified on admission to the Emergency Department of our tertiary hospital from January 2016 to January 2018. Patients with scheduled surgery who met the inclusion criteria and provided written informed consent were included in the study.
Patients were randomly allocated to a study group by permuted blocks of randomly mixed sizes and stratification according to the type of surgery (CMN or SHS). Randomization was applied using pre-prepared randomization cards, which were placed in opaque sealed envelopes and given to the surgeons to open just prior to surgery, and the designated procedure was then performed.
- Conditions
- Hip Fractures, Osteoporotic Fractures
- Being tested
- cephalomedullary nail, sliding hip screw
- Keywords
- Basicervical, Cervicobasiler, Hip, Fracture, Prospective randomized
- Medical subject headings
- Hip Fractures, Osteoporotic Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cephalomedullary nailDevice
For patients in the cephalomedullary nail group, an incision was made in the gluteal area from the tip of the greater trochanter in proximal orientation. A guidewire was placed into the medullary canal from slightly medial to the exact tip of the greater trochanter. The entry point of the greater trochanter and proximal medullary canal were reamed. The cephalomedullary nail was then inserted and fixed to the femoral head with a double screw. The cephalomedullary nail was then locked distally using a guide arm. These cephalomedullary nails were not locked proximally to maintain dynamization and to allow compression across the basicervical fracture line.
sliding hip screwDevice
For patients in the sliding hip screw group, a lateral incision was made over the lateral proximal aspect of the femur. Under fluoroscopic guidance, the lag screw was placed centrally in the femoral head over the guidewire. A side plate with three holes was then attached to the hip screw.
| Study group | Role | What they receive |
|---|---|---|
| cephalomedullary nail | Active comparator | Cephalomedullary nails was inserted and fixed to the femoral head. In this study, all patients were treated with short nails (Profin®, TST). Receives: Device: cephalomedullary nail; Device: sliding hip screw |
| sliding hip screw | Active comparator | Sliding hip screws was inserted and fixed to the femoral head. In this study, all patients were treated with a side plate with three holes (DHS plate, TST). Receives: Device: cephalomedullary nail; Device: sliding hip screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
mobility score
Functional outcome was assessed by the mobility score of Parker and Palmer (Parker MJ, Palmer CR (1993) A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br 75: 797-798), which uses a nine-point scale.
Measured: 12 months
Harris hip score
Hip function was rated with Harris Hip Score. The score has a maximum of 100 points (best possible function), covering pain (1 item, 0-44 points), function and activities (7 items, 0-47 points), and range of motion and absence of deformity (3 items, 0-9 points).
Measured: 12 months
modified Barthel index
Barthel Index (Mahoney FI, Barthel DW (1965) Functional evaluation: the Barthel Index. A simple index of independence useful in scoring improvement in the rehabilitation of the chronically ill. Md State Med J 13:61-65), which measures the level of functional independence for 10 activities of daily living and ranges from 0 to 100.
Measured: 12 months
the tip-apex distance
It uses a numerical value (the distance between tip of screw and subchondral area) to show placement of the screw in the head: higher values indicating higher likelihood of fixation failure by extrusion of the screw.
Measured: 12 months
fracture settling
It uses a numerical value to show placement of shortening of the fractured femoral neck in time
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jan 2016
- Primary completion27 Dec 2017
- Study completion1 Jan 2018
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.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Huseyin Bilgehan Cevik, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240743
- Sponsor's protocol ID
- 2015/514/74/7
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intramedullary and Extramedullary Fixation of Basicervical Fractures of the Femur in the Elderly: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04240743
- Acronym / sponsor ID
- 2015/514/74/7
- Conditions
- Hip Fractures, Osteoporotic Fractures
- Keywords
- Basicervical, Cervicobasiler, Hip, Fracture, Prospective randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 27 Dec 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 27 Jan 2020 (actual)
- 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.
This prospective, randomized study included patients aged over 65 years with basicervical fracture of femur from January 2016 to January 2018. The permuted block randomization method was used to randomize participants into groups. The patients were allocated to one of two groups treated via cephalomedullary nail (CMN) or sliding hip screw (SHS). Functional and radiological evaluations was included the mobility score, Harris hip score, modified Barthel index, the Singh index, the tip-apex distance, and fracture settling.
Detailed description
Approval for this prospective randomized study was granted by the Local Ethics Review Board and all procedures were performed in accordance with the ethical standards of the Declaration of Helsinki (1964). Patients with a basicervical femur fracture were identified on admission to the Emergency Department of our tertiary hospital from January 2016 to January 2018. Patients with scheduled surgery who met the inclusion criteria and provided written informed consent were included in the study.
Patients were randomly allocated to a study group by permuted blocks of randomly mixed sizes and stratification according to the type of surgery (CMN or SHS). Randomization was applied using pre-prepared randomization cards, which were placed in opaque sealed envelopes and given to the surgeons to open just prior to surgery, and the designated procedure was then performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cephalomedullary nail | Active comparator | Device: cephalomedullary nail, Device: sliding hip screwCephalomedullary nails was inserted and fixed to the femoral head. In this study, all patients were treated with short nails (Profin®, TST). |
| sliding hip screw | Active comparator | Device: cephalomedullary nail, Device: sliding hip screwSliding hip screws was inserted and fixed to the femoral head. In this study, all patients were treated with a side plate with three holes (DHS plate, TST). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- basicervical fracture,
- age of ≥65 year,
- an isolated fracture,
- the ability to walk independently (with or without an aid) prior to fracture,
- a fracture that had occurred less than one week prior to admission.
Key exclusion criteria (6 listed)
- history of ipsilateral femoral fracture,
- a fracture due to malignancy,
- limited life expectancy due to medical comorbidities,
- any contraindication to surgery,
- diagnosed dementia,
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 |
|---|---|---|
| cephalomedullary nailFor patients in the cephalomedullary nail group, an incision was made in the gluteal area from the tip of the greater trochanter in proximal orientation. A guidewire was placed into the medullary canal from slightly medial to the exact tip of the greater trochanter. The entry point of the greater trochanter and proximal medullary canal were reamed. The cephalomedullary nail was then inserted and fixed to the femoral head with a double screw. The cephalomedullary nail was then locked distally using a guide arm. These cephalomedullary nails were not locked proximally to maintain dynamization and to allow compression across the basicervical fracture line. | Device | cephalomedullary nail, sliding hip screw |
| sliding hip screwFor patients in the sliding hip screw group, a lateral incision was made over the lateral proximal aspect of the femur. Under fluoroscopic guidance, the lag screw was placed centrally in the femoral head over the guidewire. A side plate with three holes was then attached to the hip screw. | Device | cephalomedullary nail, sliding hip screw |
Primary outcome
mobility score
Time frame: 12 months
Functional outcome was assessed by the mobility score of Parker and Palmer (Parker MJ, Palmer CR (1993) A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br 75: 797-798), which uses a nine-point scale.
Harris hip score
Time frame: 12 months
Hip function was rated with Harris Hip Score. The score has a maximum of 100 points (best possible function), covering pain (1 item, 0-44 points), function and activities (7 items, 0-47 points), and range of motion and absence of deformity (3 items, 0-9 points).
modified Barthel index
Time frame: 12 months
Barthel Index (Mahoney FI, Barthel DW (1965) Functional evaluation: the Barthel Index. A simple index of independence useful in scoring improvement in the rehabilitation of the chronically ill. Md State Med J 13:61-65), which measures the level of functional independence for 10 activities of daily living and ranges from 0 to 100.
the tip-apex distance
Time frame: 12 months
It uses a numerical value (the distance between tip of screw and subchondral area) to show placement of the screw in the head: higher values indicating higher likelihood of fixation failure by extrusion of the screw.
fracture settling
Time frame: 12 months
It uses a numerical value to show placement of shortening of the fractured femoral neck in time
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 27 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cephalomedullary nail and sliding hip screw in people with Hip Fractures and Osteoporotic Fractures, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital.
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 5 inclusion and 6 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
mobility score (time frame: 12 months). The study lists 5 primary outcomes in all. 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 27 Jan 2020.