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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 Fol

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 Summary:

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 H
Sponsor: Hebei Medical University Third Hospital

Current Primary Outcome: Harris hip scores [ Time Frame: Changes of baseline and 6 months after operation ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: X-ray image [ Time Frame: Changes of baseline and month 6, month 12, month 24 after operation ]

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.


Original Secondary Outcome: Same as current

Information By: Hebei Medical University Third Hospital

Dates:
Date Received: November 24, 2016
Date Started: January 2015
Date Completion: June 2017
Last Updated: December 1, 2016
Last Verified: December 2016