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

Total Hip Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02981823
• Other study ID #: HebeiMUTH_QD_001
• Status: Active, not recruiting
• Phase: N/A
• First received: November 24, 2016
• Last updated: December 1, 2016
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: December 2016
• Source: Hebei Medical University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periprosthetic Fractures
• Total Hip Arthroplasty

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Changes of baseline and 6 months after operation	No
Secondary	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.	Changes of baseline and month 6, month 12, month 24 after operation	No