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Feasibility of Implantation of Cemented Femoral Stem for Osteoporotic Femoral Neck Fracture in Elderly Patients

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ClinicalTrials.gov Identifier: NCT02901938
Recruitment Status : Unknown
Verified September 2016 by Rong, Qinghai University.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Rong, Qinghai University

Brief Summary:
This study will investigate the effects of implantation of cemented femoral stem versus percutanous internal fixation with cannulated compression screws on hip joint function recovery, pains, femoral head collapse and sterile prosthesis loosening, peri-prosthesis infection, and the histocompatibility of prosthesis material with host tissue in the elderly patients with osteoporotic fracture of proximal femoral neck complicated by avascular necrosis of the femoral head, which will provide scientific evidence for selecting surgical methods and internal fixation/artificial prosthesis material for osteoporotic fracture of proximal femoral neck in the elderly patients.

Condition or disease Intervention/treatment Phase
Femoral Neck Fracture Procedure: cemented femoral stem Device: cannulated compression screws Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Implantation of Cemented Femoral Stem in the Treatment of Osteoporotic Femoral Neck Fracture in Elderly Patients: a Randomized Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2018

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Arm Intervention/treatment
Experimental: cemented femoral stem group
The patients with avascular necrosis of the femoral head complicated by osteoporotic femoral neck fracture will be randomly assigned to undergo implantation of cemented femoral stem.
Procedure: cemented femoral stem
The patients assigned even numbers will undergo implantation of cemented femoral stem.

Experimental: cannulated compression screws group
The patients with avascular necrosis of the femoral head complicated by osteoporotic femoral neck fracture will be randomly assigned to undergo percutaneous internal fixation with cannulated compression screws.
Device: cannulated compression screws
The patients assigned even numbers will undergo percutaneous internal fixation with cannulated compression screws.




Primary Outcome Measures :
  1. Changes of Harris hip scores [ Time Frame: at baseline, 1, 6 and 12 months after surgery ]
    To evaluate the recovery of hip joint function from the domains covering pain, function, absence of deformity, and range of motion, 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.


Secondary Outcome Measures :
  1. Changes of VAS scores [ Time Frame: at baseline, 1, 6 and 12 months after surgery ]
    To evaluate the severity of pain and ranges from 0-10, with higher scores indicating more severe pain. A score of 0 represents no pain, scores > 0 and ≤ 3 represent mild pain, scores > 3 and ≤ 6 moderate pain, and scores > 6 and ≤ 10 severe pain.



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with avascular necrosis of the femoral head diagnosed according to the previous criteria: Bone nonunion as indicated by a clear fracture line on X-ray images 12 months after femoral neck fracture; cystic degeneration, sclerosis, and uneven density on X-ray images and CT scans
  • Patients with osteoporosis diagnosed according to a previous report: Bone density T value < -2.5 or bone mass decrease by 25%
  • Patients with femoral neck fracture diagnosed according to the previous criteria (Chen and Wang, 2013): Presence of a fracture line on anterior- posterior X-ray images of the hip joint, and CT and MRI examination in combination with clinical symptoms and physical sign are necessary if no fracture line appears
  • Age 60-80 years
  • Healthy and able to tolerate anesthesia and surgery
  • Provision of informed consent about participation and trial procedure

Exclusion Criteria:

  • Alcohol abuse or long-term use of hormone drugs
  • Infection of tissue around the hip joint
  • Bone metabolism disorders other than osteoporosis, such as renal osteodystrophy and osteomalacia
  • Heart, lung, brain, or other systemic diseases
  • Advanced malignant tumor
  • Recent cerebral hemorrhage, myocardial infarction, or failure of important organs
  • Injured limb with deep venous thrombosis
  • Inability to tolerate surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901938


Sponsors and Collaborators
Qinghai University
Investigators
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Principal Investigator: Rong Ren, Master Affiliated Hospital of Qinghai University

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Responsible Party: Rong, Attending Physician, Qinghai University
ClinicalTrials.gov Identifier: NCT02901938     History of Changes
Other Study ID Numbers: QinghaiUH_004
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries