Clinical Trial: Supercapsular Percutaneously Assisted Total Hip Approach for the Elderly With Femoral Neck Fractures

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

Official Title: Supercapsular Percutaneously Assisted Total Hip Approach for the Elderly With Femoral Neck Fractures: a Prospective, Open-label, Randomized, Controlled Clinical Trial

Brief Summary: To test that the SuperPATH approach is more safe and reliable for hip functional recovery compared with the postolateral approach in the artificial hip replacement for femoral neck fractures in the elderly.

Detailed Summary:

Femoral neck fracture is one of the most common diseases in the elderly. Artificial hip replacement is currently the preferred treatment for femoral neck fractures, and characterized by no presence of postoperative bone nonunion, femoral head necrosis and other complications, though longer operative time and larger surgical incision are unavoidable. Patients undergoing artificial hip replacement can recover weight-bearing walk early after surgery, making rehabilitation rapid, to avoid a variety of complications, such as bed rests. Hip replacement via posterolateral approach is generally used, but limited by large incision, cutting off the extortor, and postoperative hip dislocation.

The minimally invasive approach for hip replacement has the advantages of less blood loss and less trauma compared with conventional approaches. The supercapsular percutaneously-assisted total hip (SuperPATH) approach (Appendix 1) is consistent with the posterolateral approach in the anatomical landmark, preserving all the advantages of the posterior approach. Compared with the conventional approaches, the SuperPATH approach has no neurovascular interface that is uneasy to damage blood vessels and nerves during operation, reducing intraoperative blood loss, and retains all of the joint capsules and supinator muscles, significantly reducing the probability of postoperative dislocation of the hip. Osteotomy via this approach can be completed without hip dislocation, thus reducing incidence of vascular distortion and postoperative deep vein thrombosis. Hip replacement via the SuperPATH approach can be completed under direct vision rather than perspective inspection, and the surgical incision on the femur is made according to the femoral anteversion angle. In addition, this approach is also used for femoral intramedullary nail implantation. These surgical procedures are more likely to be grasped b
Sponsor: Shanghai Pudong Hospital

Current Primary Outcome: Harris hip scores [ Time Frame: changes of baseline, week 1 and month 6 postoperatively ]

To assess hip function recovery in patients. The hip function is assessed by Harris scores ranging from 0-100: excellent ≥ 90, good 80-90, fair 70-79, bad < 70. The higher scores indicate better hip function.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of surgical incision [ Time Frame: during the surgery ]
    A smaller surgical incision causes smaller surgical trauma to patients.
  • Intraoperative blood loss [ Time Frame: during the surgery ]
    Less blood loss indicates the surgical practice is more normative and safe.


Original Secondary Outcome: Same as current

Information By: Shanghai Pudong Hospital

Dates:
Date Received: April 26, 2017
Date Started: January 2015
Date Completion: December 2017
Last Updated: April 26, 2017
Last Verified: April 2017