An interventional study of RhBMP-2 in Osteoporosis and Spinal Fusion, sponsored by Xijing Hospital. Status unknown. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment
rhBMP-2 has been used to promote spinal fusion. Despite potential risk of complications, satisfied results could be obtained with low dose of rhBMP-2. Effect of early bone formation has been validated using rat ovariectomy osteoporosis model. However, whether it functioned in patients with osteoporosis remained unknown. In this study, the investigators intend to investigate whether rhBMP-2 promotes early bone formation in patients with osteoporosis after transforaminal lumbar interbody fusion (TLIF).
Pseudoarthrosis and many complications associated with iliac crest bone graft (ICBG) has prompted the spine surgeons to seek alternative methods to promote rate of spinal fusion. The rhBMP-2 received FDA approval in 2002 for use as an alternative to autograft for single-level anterior lumbar interbody fusion (ALIF). Many studies reported equivalent or better fusion rates. Recent studies, however, identified complications related to rhBMP-2 use such as osteolysis, graft subsidence, and retrograde ejaculation and other urological complications. Overdose of rhBMP-2 in patients may lead to complications mentioned above. A recent randomized controlled trial in 2022 confirmed a low dose usage of rhBMP-2 promoted fusion after TLIF (21.mg per fusion level) without increase in complications.
Current fusion methods achieve interbody fusion by filling the cage in the central region of the intervertebral space with bone graft material. However, the early fusion rates (at 3 and 6 months postoperatively) are often unsatisfactory. According to present literatures, the 3-month and 6-month fusion rates have ranged from 2.9% to 43.1% and 30% to 68.8%, respectively. Although a lack of fusion may be asymptomatic, it may potentially lead to complications, even a reoperation. In addition, failure to achieve early fusion may result in a delayed return to work, and reduced patient satisfaction, especially in patients with osteoporosis. Whether rhBMP-2 may lead to higher and early fusion rate in osteoporosis patient remains unknown.
In this study, the investigators intend to compare the time it takes to achieve osseous union/fusion and the clinical efficacy of using rhBMP-2 to control group in TLIF. The rhBMP-2 in the study is produced by a domestic enterprise (HANGZHOU JIUYUAN GENE ENGINEERING CO .,LTD., Hangzhou, China).
1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.
This study's planned enrollment of 76 is below the median of 95 across 1,152 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
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Exclusion Criteria:
Drug: RhBMP-2
1mg RhBMP-2 for one fusion-level
Fusion rate at 6 months
1. \<5°of angular motion, ≤3 mm of translation from lumbar spine dynamic radiographs 2. Bridging bone connecting the adjacent vertebral bodies either through the implants or around the implants, and an absence of radiolucent lines around \>50% of either implant from computed tomography (CT) scans of lumbar
Time frame: 6 months follow-up
Fusion rate at 3 months
\<5°of angular motion, ≤3 mm of translation from lumbar spine dynamic radiographs of radiolucent lines around \>50% of either implant
Time frame: 3 months follow-up
Visual Analog Score for low back pain (VAS-B)
range from 0-10, a higher score means a worse outcome.Short Form Survey (SF-36)
Time frame: pre- and post-operative immediately, 3- and 6- months follow-up
Visual Analog Score for leg pain (VAS-L)
range from 0-10, a higher score means a worse outcome.
Time frame: pre- and post-operative immediately, 3- and 6- months follow-up
Oswestry disability index (ODI)
range from 0-100%, a higher score means a worse outcome.
Time frame: pre-operatively, 3- and 6-months follow-up
36-Item Short Form Survey (SF-36)
As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36) in 1992. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
Time frame: pre-operatively, 3- and 6-months follow-up
Incidence of complications
infection, revision surgery, etc.
Time frame: post-operative immediately, 3- and 6- months follow-up
No study locations are listed for this record.
Plan to share: Yes — Other researchers should ask for permissions from the investigator.
Supporting information: Study protocol, Statistical analysis plan
Time frame: one year after the study is finished.
Access criteria: Through emails after Obtaining written permission from the investigator
No publications or documents are linked to this record.
Start is estimated for Jul 2023; primary completion for Dec 2023, 5 months later.
Of 228 non-industry interventional studies with no phase under Osteoporosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 44. This study's planned 5 months is below that.
Counting every sponsor, half of 246 studies reached it within 22 months; a quarter within 9 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dibotermin alfa