Prospective, Randomized, Controlled Trial of Silicate-Substituted Calcium Phosphate Versus rhBMP-2 in a Minimally Invasive Transforaminal Lumbar Interbody Fusion
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Post-publication record
- Nature
- Retraction
- Reason
- Error by Third Party;Error in Methods;Error in Text;Miscommunication with/by Third Party;
- Date
- 3/1/2016 0:00
- Flagged by OpenAlex?
- Yes
Source: Retraction Watch, joined by DOI. OpenAlex records retraction as is_retracted, a boolean over a state space with at least four values, so it cannot express an expression of concern, a correction or a reinstatement — it reports them as false, which reads as “fine”.
Abstract
In Brief Study Design. Prospective, randomized, controlled trial. Objective. To compare arthrodesis rates between patients undergoing a primary single-level minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) with either Actifuse or recombinant human bone morphogenetic protein-2 (rhBMP-2). Summary of Background Data. Preclinical animal studies suggest that silicate-substituted calcium phosphate (Actifuse) bone graft substitute offers equivalent or an increased fusion rate compared with other graft enhancers/extenders and rhBMP-2. Methods. Fifty-two patients undergoing a single-level unilateral MIS TLIF were evenly randomized into 2 cohorts as follows: the Actifuse cohort received Actifuse combined with 5 mL of bone marrow aspirate (n = 26; 50%), whereas the rhBMP cohort received 4.2 mg of rhBMP-2 (n = 26; 50%). A pre hoc G*Power analysis yielded a sample size of n = 26 that was determined through a 2-tailed distribution calculation. Computed tomographic analysis was performed at 6 months and 1 year postoperatively. Pre- and postoperative visual analogue scale scores were obtained to assess the clinical outcomes. Arthrodesis was determined by 2 separate, blinded orthopedic surgeons and a board certified radiologist. Results. At 1-year follow-up, 65% (17/26) of the Actifuse cohort and 92% (24/26) of the rhBMP-2 cohort demonstrated a radiographical arthrodesis (P = 0.01). In both study cohorts, the 1-year postoperative visual analogue scale scores significantly improved (P < 0.001). Pseudarthrosis rates at 1 year were 35.0% (9/26) and 7.7% (2/26) for the Actifuse and rhBMP-2 groups, respectively (P = 0.01, OR = 6.35, 95% CI = 1.22–33.1). A greater reoperation rate was noted in the Actifuse cohort (35.0%, 9/26) compared with the BMP-2 cohort (7.7%, 2/26; P = 0.01). One patient with BMP-2 also experienced symptomatic neuroforaminal bone growth (3.8%, n = 1/26). Conclusion. Silicate-substituted calcium phosphate was associated with a significantly lower rate of arthrodesis than rhBMP-2 in a MIS TLIF. The patients with pseudarthrosis in both cohorts were all clinically symptomatic with an unimproved visual analogue scale score. Additional analysis of Actifuse and other graft enhancers/extenders are needed prior to the utilization for an MIS TLIF. Level of Evidence: 2 In this prospective, randomized, controlled trial in the setting of a minimally invasive transforaminal lumbar interbody fusion, the Actifuse cohort demonstrated a lower arthrodesis rate and higher reoperation rate, at 1-year follow-up, than the recombinant human bone morphogenetic protein-2 cohort. One-year visual analogue scale scores were unimproved among patients in both cohorts with a computed tomography confirmed pseudarthrosis.
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The record
- Venue
- Spine
- Topic
- Spine and Intervertebral Disc Pathology
- Field
- Medicine
- Canadian institutions
- Discovery Air (Canada)
- Funders
- —
- Keywords
- MedicineSurgeryArthrodesisPseudarthrosisRandomized controlled trialVisual analogue scaleCohortLumbarOrthopedic surgeryProspective cohort studySpinal fusionInternal medicine
- Has abstract in OpenAlex
- yes