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Effect of Periprosthetic Fracture on Hip Function After Femoral Neck-preserving Total Hip Arthroplasty

Primary Purpose

Total Hip Arthroplasty

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hip replacement
Sponsored by
Hebei Medical University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Hip Arthroplasty

Eligibility Criteria

undefined - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnostic and staging criteria in line with the Expert consensus on diagnosis and treatment of adult femoral head necrosis
  • Femoral head necrosis of Association Research Circulation Osseous (ARCO) stages III-IV
  • Unilateral femoral head necrosis
  • Age < 50 years
  • Both genders

Exclusion Criteria:

  • Advanced osteoarthritis
  • Secondary osteoarthritis due to acetabular dysplasia
  • Ankylosing spondylitis involving the hip joint
  • Rheumatoid arthritis
  • Inflammatory inflammation of the hip joint
  • Tumor lesions in the hip joint
  • Unable or refusal to sign the informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    hip replacement

    Arm Description

    The patients undergo total hip replacement with the collum femoris preserving stem suffered from periprosthetic fractures.

    Outcomes

    Primary Outcome Measures

    Harris hip scores
    To evaluate the recovery of hip joint function. Harris hip scores have a range of 0-100 points: excellent ≥ 90 points, good 80-89 points, fair 70-79 points, and poor <70 points. The higher score indicates the better function of the hip.

    Secondary Outcome Measures

    X-ray image
    To observe anteroposterior and frog-leg lateral X-ray films of the hip as well as full-length X-ray films of the bilateral lower extremities.

    Full Information

    First Posted
    November 24, 2016
    Last Updated
    December 1, 2016
    Sponsor
    Hebei Medical University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02981823
    Brief Title
    Effect of Periprosthetic Fracture on Hip Function After Femoral Neck-preserving Total Hip Arthroplasty
    Official Title
    Effect of Periprosthetic Fracture on Hip Function After Femoral Neck-preserving Total Hip Arthroplasty: a Prospective, Single-center, Self-controlled Trial With 2-year Follow-up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hebei Medical University Third Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To provide information on reducing the incidence of periprosthetic fractures during hip replacement with the CFP prosthetic stem by analyzing the risk factors for periprosthetic fractures and their effects on hip functional recovery.
    Detailed Description
    History and current related studies Periprosthetic fractures are one of the challenges for orthopedic surgeons that are more likely to appear during hip replacement with a cementless prosthesis. Hip replacement with a collum femoris preserving (CFP) prosthetic stem allows the preservation of the femoral neck and preserves bone tissues as much as possible for prosthetic revision in the future. However, the occurrence of periprosthetic fractures will result in a failure surgery. Existing evidence has shown that although hip replacement with the CFP prosthetic stem can reduce complications and pain, periprosthetic fractures that are more likely to occur during the surgery badly impact functional recovery in patients. Adverse events Adverse events which occurred during the follow-up, including hip pain, prosthetic loosening, spinal cord and nerve injuries, soft tissue infection and poor prosthetic position, were recorded. If severe adverse events occurred during the follow-up, their details including the date of occurrence, type of adverse events and measures taken were recorded and reported to the principal investigator and the institutional review board within 24 hours. Data collection, management, analysis, and open access Data collection Clinical data, including demographic data, disease diagnosis, accompanying diseases, allergic history (drug allergy) and adverse events, were collected and summarized using standardized case report forms. These data were processed using Epidata software and electronically input using double entry system. Data management After database confirmation, only the project manager was able to access the database. The locked data were unable to be altered and were preserved by the Third Hospital of Hebei Medical University. Data analysis All data were statistically analyzed by professional statisticians who were responsible for completing an outcome analysis report that was submitted to the project manager. An independent data monitoring committee was responsible for data monitoring and management throughout the entire trial to ensure scientific accuracy, stringency, authenticity, and integrity. Statistical analysis All data were statistically analyzed by statisticians using SPSS 21.0 software in line with the intention-to-treat principle. Normally distributed measurement data were expressed as means, standard deviations, minimums, and maximums, while non-normally distributed data were expressed as lower quartiles, medians, and upper quartiles. Wilcoxon matched paired test was used for comparative analysis of Harris hip scores and imaging parameters as determined before and 6, 12, 24 months after operation. Then, a multivariate logistic regression analysis was used to calculate the regression coefficient, OR, 95% CI with the Harris scale as the dependent variable for each imaging parameter which had significant difference. The statistical significance level was α = 0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Total Hip Arthroplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    hip replacement
    Arm Type
    Experimental
    Arm Description
    The patients undergo total hip replacement with the collum femoris preserving stem suffered from periprosthetic fractures.
    Intervention Type
    Procedure
    Intervention Name(s)
    hip replacement
    Intervention Description
    The patients undergo hip replacement with the collum femoris preserving stem suffered from periprosthetic fractures.
    Primary Outcome Measure Information:
    Title
    Harris hip scores
    Description
    To evaluate the recovery of hip joint function. Harris hip scores have a range of 0-100 points: excellent ≥ 90 points, good 80-89 points, fair 70-79 points, and poor <70 points. The higher score indicates the better function of the hip.
    Time Frame
    Changes of baseline and 6 months after operation
    Secondary Outcome Measure Information:
    Title
    X-ray image
    Description
    To observe anteroposterior and frog-leg lateral X-ray films of the hip as well as full-length X-ray films of the bilateral lower extremities.
    Time Frame
    Changes of baseline and month 6, month 12, month 24 after operation

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnostic and staging criteria in line with the Expert consensus on diagnosis and treatment of adult femoral head necrosis Femoral head necrosis of Association Research Circulation Osseous (ARCO) stages III-IV Unilateral femoral head necrosis Age < 50 years Both genders Exclusion Criteria: Advanced osteoarthritis Secondary osteoarthritis due to acetabular dysplasia Ankylosing spondylitis involving the hip joint Rheumatoid arthritis Inflammatory inflammation of the hip joint Tumor lesions in the hip joint Unable or refusal to sign the informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Di Qin, Ph.D
    Organizational Affiliation
    Hebei Medical University Third Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Periprosthetic Fracture on Hip Function After Femoral Neck-preserving Total Hip Arthroplasty

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