Fixation Methods of Basicervical Fractures
Primary Purpose
Hip Fractures, Osteoporotic Fractures
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cephalomedullary nail
sliding hip screw
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring Basicervical, Cervicobasiler, Hip, Fracture, Prospective randomized
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
cephalomedullary nail
sliding hip screw
Arm Description
Cephalomedullary nails was inserted and fixed to the femoral head. In this study, all patients were treated with short nails (Profin®, TST).
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).
Outcomes
Primary Outcome Measures
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.
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).
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.
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.
fracture settling
It uses a numerical value to show placement of shortening of the fractured femoral neck in time
Secondary Outcome Measures
Full Information
NCT ID
NCT04240743
First Posted
January 17, 2020
Last Updated
January 22, 2020
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04240743
Brief Title
Fixation Methods of Basicervical Fractures
Official Title
Comparison of Intramedullary and Extramedullary Fixation of Basicervical Fractures of the Femur in the Elderly: a Prospective, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 27, 2017 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Osteoporotic Fractures
Keywords
Basicervical, Cervicobasiler, Hip, Fracture, Prospective randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cephalomedullary nail
Arm Type
Active Comparator
Arm Description
Cephalomedullary nails was inserted and fixed to the femoral head. In this study, all patients were treated with short nails (Profin®, TST).
Arm Title
sliding hip screw
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
cephalomedullary nail
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sliding hip screw
Intervention Description
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.
Primary Outcome Measure Information:
Title
mobility score
Description
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.
Time Frame
12 months
Title
Harris hip score
Description
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).
Time Frame
12 months
Title
modified Barthel index
Description
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.
Time Frame
12 months
Title
the tip-apex distance
Description
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.
Time Frame
12 months
Title
fracture settling
Description
It uses a numerical value to show placement of shortening of the fractured femoral neck in time
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Fixation Methods of Basicervical Fractures
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