An interventional study of percutaneous vertebroplasty and conservative treatment in Spinal Fractures, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-05.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over China, but the efficacy and essentiality of the surgery remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment. Because of the procedure , neither patients nor investigators were blinded. The primary outcome was pain relief at 1 month and 1 year.
This study will use a randomised controlled trial to access the efficacy and essentiality of the surgery for vertebral compression fractures. Patients aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss) will be invited to take part. Patients will be randomised into 2 arms with average amount. The participants in the intervention arm will have percutaneous vertebroplasty ; those randomised to the control arm will receive current standard conservative treatment methods.
Patients were clinically assessed at baseline (the day of surgery or treatment), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year afterwards. The primary outcome will be the pain release , categorised according to WHO classification.
144 studies on the registry are indexed under Spinal Fractures; 24 are open to participants now.
This study's planned enrollment of 400 is above the median of 85 across 85 interventional studies indexed under Spinal Fractures.
Browse Spinal Fractures studies →Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
percutaneous vertebroplasty
Procedure: percutaneous vertebroplasty
conservative treatment
Procedure: conservative treatment
Undertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement.
complete on bed with prevention of complications
change of pain relief
World Health Organization pain classification
Time frame: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
quality of life
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
Time frame: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2018; primary completion for Jan 2020, 23 months later.
Of 36 interventional studies with no phase under Spinal Fractures, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 70. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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