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

NCT03134664 | Unknown DMC

• 1 other identifier: ShanghaiPudongH_002
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Length of surgical incision

  during the surgery

• Intraoperative blood loss

  during the surgery

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients with femoral neck fractures are randomly assigned to undergo femoral head replacement via the SuperPATH approach in the experimental group.

Procedure: Experimental group

Control group

EXPERIMENTAL

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

Interventions

Experimental group PROCEDURE

Patients with femoral neck fractures are randomly assigned to undergo femoral head replacement via the SuperPATH approach in the experimental group.

Experimental group

Control group PROCEDURE

Patients with femoral neck fractures are randomly assigned to undergo femoral head replacement via the conventional posterior approach in the control group.

Control group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Pudong Hospital: lead

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Lianghao Wu, Ph.D

  Pudong Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Forty patients with femoral neck fractures admitted at Pudong Hospital of Fudan University, China are randomly divided into two groups.

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: January 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 1, 2017

Record last verified: 2017-04