Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03134664
Other study ID # ShanghaiPudongH_002
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 26, 2017
Last updated April 26, 2017
Start date January 2015
Est. completion date December 2017

Study information

Verified date April 2017
Source Shanghai Pudong Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Experimental group
Patients with femoral neck fractures are randomly assigned to undergo femoral head replacement via the SuperPATH approach in the experimental group.
Control group
Patients with femoral neck fractures are randomly assigned to undergo femoral head replacement via the conventional posterior approach in the control group.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Pudong Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Length of surgical incision A smaller surgical incision causes smaller surgical trauma to patients. during the surgery
Secondary Intraoperative blood loss Less blood loss indicates the surgical practice is more normative and safe. during the surgery
See also
  Status Clinical Trial Phase
Recruiting NCT05505604 - PENG vs FICB for Hip Fracture in ED Patients N/A
Recruiting NCT04462172 - A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck Fracture N/A
Enrolling by invitation NCT04110639 - Intraoperative Monitoring of Femoral Head Perfusion N/A
Terminated NCT01908751 - Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) Phase 3
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Recruiting NCT01219088 - Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw Phase 4
Not yet recruiting NCT00749710 - Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel N/A
Active, not recruiting NCT00491673 - A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures N/A
Completed NCT00464230 - Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures Phase 4
Recruiting NCT03966716 - Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR) N/A
Recruiting NCT05227924 - Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
Completed NCT03666637 - Femoral Neck Fracture in Adult and Avascular Necrosis and Nonunion
Terminated NCT03721835 - Safety Study of Femoral Neck Fracture System N/A
Not yet recruiting NCT04408053 - Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture Phase 3
Recruiting NCT04577261 - FNS (FEMORAL NECK SYSTEM) Study
Recruiting NCT04589598 - Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture N/A
Not yet recruiting NCT06078371 - Opioid-Free Pain Treatment in Trauma Patients N/A
Withdrawn NCT02198820 - Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome N/A
Active, not recruiting NCT02246335 - Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly N/A
Not yet recruiting NCT00926666 - A Dose Finding Study for Pain Relief of a Broken Hip Phase 4