UnknownNot Applicable

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

100 participantsStarted 2016-01

Plain-language 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.

Who can participate

Age range

60 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes of Harris hip scores

Timeframe: at baseline, 1, 6 and 12 months after surgery

Trial details

NCT IDNCT02901938

SponsorQinghai University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06

View on ClinicalTrials.gov More Femoral Neck Fracture trials