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
About this trial
This is an interventional treatment trial for Total Hip Arthroplasty
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
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
NCT ID
NCT02981823
First Posted
November 24, 2016
Last Updated
December 1, 2016
Sponsor
Hebei Medical University Third Hospital
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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