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
|Condition or disease||Intervention/treatment||Phase|
|Femoral Neck Fracture||Procedure: cemented femoral stem Device: cannulated compression screws||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|Principal Investigator:||Rong Ren, Master||Affiliated Hospital of Qinghai University|