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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
Dr. Lutfi Kirdar Kartal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Basicervical, Cervicobasiler, Hip, Fracture, Prospective randomized

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 17, 2020
    Last Updated
    January 22, 2020
    Sponsor
    Dr. Lutfi Kirdar Kartal Training and Research Hospital
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    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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