Porous Tantalum Rods Improve the Hip Joint Function of Patients With Avascular Necrosis of the Femoral Head

NCT02877472 | Unknown DMC

• 1 other identifier: QinghaiUH_003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To confirm 1) whether, compared with core decompression alone, core decompression with porous tantalum rod implantation improves the hip joint function of patients with avascular necrosis of the femoral head after femoral neck fracture surgery, 2) whether porous tantalum rod shows favorable biocompatibility with the human body, and 3) whether this treatment method is feasible for treating avascular necrosis of the femoral head after femoral neck fracture surgery.

Conditions

Femoral Neck Fracture

Outcome Measures

Primary Outcomes (1)

• Harris hip scores

  To evaluate the recovery of hip joint function. The Harris hip score ranges from 0-100 points with higher scores indicating better hip joint function. Hip joint function is scored as follows: ≥ 90 is excellent, 80-89 very good, 70-79 good, and \< 70 poor.

  12 months after surgery

Secondary Outcomes (2)

• Visual Analogue Scale (VAS)

  prior to and 1, 6, and 12 months after surgery

• Incidences of complications

  6 and 12 months after surgery

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients with avascular necrosis of the femoral head after femoral neck fracture surgery will undergo core decompression and porous tantalum rod implantation (experimental group).

Device: porous tantalum rod

Control group

EXPERIMENTAL

Patients with avascular necrosis of the femoral head after femoral neck fracture surgery will undergo core decompression (control group).

Procedure: core decompression

Interventions

porous tantalum rod DEVICE

Patients with avascular necrosis of the femoral head after femoral head fracture surgery receive treatment of core decompression and porous tantalum rod implantation

Also known as: Experimental group

Experimental group

core decompression PROCEDURE

Patients with avascular necrosis of the femoral head after femoral head fracture surgery will undergo core decompression.

Also known as: Control group

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with fracture nonunion as indicated by a clear fracture line 12 months after femoral neck fracture; avascular necrosis of the femoral head as shown by cystic degeneration, sclerosis, and uneven density on X-ray images and CT scans
• Patients with avascular necrosis of the femoral head after femoral neck fracture surgery who underwent internal fixation between 1 January 2016 and 31 May 2017
• Age 18-80 years
• Any sex and nationality
• Provision of signed informed consent to participate in the trial

You may not qualify if:

• Poor general health
• Chronic disease or history of surgery
• Alcohol abuse or long-term use of hormone drugs
• Unable or declines to cooperate with treatment and examination because of language and/or mental disorders
• Unable or declines to cooperate with rehabilitation treatment because of mental and/or psychological disorders

Sponsors & Collaborators

• Qinghai University: lead

Study Sites (1)

Qinghai University Affiliated Hospital

Xining, Qinghai, 810001, China

RECRUITING

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

• Heling Zhang, Master

  Affiliated Hospital of Qinghai University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heling Zhang, Master

CONTACT

8613997262938; helingzhang_qu@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 24, 2016
• Study Start: May 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: May 1, 2017
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

CN (1)