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

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

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.

Study Overview

• Status: Unknown
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: Procedure: Experimental group; Procedure: Control group

Detailed Description

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 by clinicians. Preservation of the joint capsule and supinator muscles makes physical activities unrestricted and speeds up rehabilitation. Moreover, there is a corresponding reduction in the hospital stay and costs. However, SuperPATH technology is rarely reported in China as it has been introduced for a short time and in few hospitals.

Previous studies have reported that SuperPATH approach for artificial hip replacement exhibits better short-term effect on elderly femoral neck fractures. In this trial, the follow-up period will be prolonged to 6 months in order to observe the short-to-mid term effect in the elderly with femoral neck fractures.

Adverse events Postoperative adverse events including incision pain and infection, back muscle pain, spinal cord/nerve injury, length inequality of the lower limbs, prosthesis falling-off and prosthetic loosening will be recorded during the follow-up period. If severe adverse events occur, details including the data of occurrence, type of adverse events and therapeutic measures will be reported to the project manager 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, and allergic history (drug allergy), will be collected and summarized using standardized case report forms. These data will be processed and recorded electronically.

Data management Researchers will be responsible for data processing, confirming and locking. The locked data will be unable to be altered and preserved by the Pudong Hospital of Fudan University. In addition to these researchers, only the persons who have permission will have the right to query the database.

Data analysis All data will be statistically analyzed by professional statisticians who will responsible for completing an outcome analysis report that will be submitted to the principle investigator who will be responsible for completing a research report. An independent data monitoring committee is responsible for data monitoring and management throughout the entire trial to ensure scientific accuracy, stringency, authenticity, and integrity.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Femoral head fractures as diagnosed by X-ran and CT;
• Garden III, IV;
• An age of > 75 years;
• Both genders.

Exclusion Criteria:

• Fractures with spinal cord injury;
• Fractures with nerve injury;
• Refusal to sign the informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; Patients with femoral neck fractures are randomly assigned to undergo femoral head replacement via the SuperPATH approach in the experimental group.	Procedure: Experimental group; Patients with femoral neck fractures are randomly assigned to undergo femoral head replacement via the SuperPATH approach in the experimental group.
EXPERIMENTAL: Control group; Patients with femoral neck fractures are randomly assigned to undergo femoral head replacement via the conventional posterior approach in the control group.	Procedure: Control group; Patients with femoral neck fractures are randomly assigned to undergo femoral head replacement via the conventional posterior approach in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris hip scores	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.	changes of baseline, week 1 and month 6 postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of surgical incision	A smaller surgical incision causes smaller surgical trauma to patients.	during the surgery
Intraoperative blood loss	Less blood loss indicates the surgical practice is more normative and safe.	during the surgery

Collaborators and Investigators

• Sponsor: Shanghai Pudong Hospital
• Investigators: Principal Investigator: Lianghao Wu, Ph.D, Pudong Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (ACTUAL): May 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: ShanghaiPudongH_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No