Single-blinded prospective randomized study comparing open versus needle technique for obtaining autologous cancellous bone from the iliac crest

One of the most frequent complications of cervical anterior discectomy with fusion is pain at the donor site, usually the iliac crest. Despite the advent of new materials, autologous bone is still the gold standard for fusion procedures. A prospective, single blinded, randomized study was performed to evaluate the effect of a minimal invasive technique to obtain autologous bone from the iliac crest on pain. The minimal invasive technique uses a large needle to obtain cancellous bone. Consecutive patients scheduled for cervical anterior discectomy with a fusion using a cage were randomly assigned either to the classical open group or the needle group. Patients were unaware of the two possible options for obtaining autologous bone. They were asked to fill in visual analogue scores (VASs) at fixed moments during the first 6 weeks postoperatively. Three VASs were recorded: the score at the moment, the minimal score and the maximal score during the last 24 h. The wound at the iliac crest was measured 6 weeks postoperatively. Complications were registered. Fifty patients were enrolled. Twenty-five patients were assigned to each group . The pain scores from the needle group were significantly less than from the open group. At 2 weeks postoperatively, nearly all patients (88%) of the needle group were free of pain at the iliac crest, whereas ten patients (40%) of the open group still had some pain. Complications only occurred in the open group. Six patients complained of diminished sensibility. In two cases, it had resolved at 6 weeks postoperatively. In one case, a hemorrhage occurred. Surgical evacuation was not necessary. Obtaining autologous cancellous bone through a large needle for filling a cervical cage (even multiple cages) is safe and evidently less painful than through a classical open procedure. If pain exists it does not last very long. Generally, the pain is resolved within 2 weeks.The preliminary findings for the first 30 patients of this study were reported on the Cervical Spine Research Society (European Section) in Barcelona in 2003.     

Autologous versus allogenic bone grafts in instrumented anterior cervical discectomy and fusion: a prospective study with respect to bone union pattern

Background The purpose of this prospective semi-randomised comparative study was to compare fusion rates, course of fusion, and occurrence of collapse and subsidence of autologous and allogenic bone grafts in instrumented anterior cervical fusion. The number of fused levels and the smoking status were investigated as potential factors influencing the bone-healing process. No similar prospective study on instrumented anterior cervical discectomy and fusion was found in the literature.Methods Seventy-nine consecutive patients were operated on using the Smith–Robinson technique with a single instrumentation system at one or two levels. Seventy-six cadaverous fibular bone grafts and 37 autologous iliac-crest bone grafts were inserted. All patients were followed up for at least 2 years.Results The radiographs obtained during the follow-up were analysed, and showed no statistical difference in fusion and collapse rate between autografts and allografts. Allografts showed significantly longer time to union. No case of graft migration was observed. No difference was found between fusion and collapse rate with respect to the number of fused levels in general, but greater time to union was seen in two-level fusions. When one- and two-level subgroups were compared, there was no evidence of any significant difference in fusion or collapse rates between autografts and allografts, and the healing process took longer in allogenic grafts. Smoking status did not alter any of the fusion or collapse rates, or the course of bone fusion.Conclusions This study demonstrates that allografts are suitable substitutes for autografts in instrumented ACDF. Prolonged time to union observed in allogenic bone grafts does not seem to be an important factor in instrumented procedures. Two-level grafting does not imply a significantly lower fusion rate, but longer time to union can be expected than with single-level instrumented procedures in both allograft and autograft subgroups. Our relatively small number of patients may not have been sufficient to decipher significant differences between smokers and non-smokers in the rate or course of fusion as previously reported.     

Platelet-rich plasma enhances bone union in posterolateral lumbar fusion: A prospective randomized controlled trial

Background Context

Platelet-rich plasma (PRP) accelerates bone union in vivo in a rodent model of spinal fusion surgery. However, PRP's effect on bone union after spinal surgery remains unclear.

复合骨形态发生蛋白(BMP)的微小颗粒骨修复兔桡骨缺损的实验研究

目的探讨自体或深低温冷冻同种异体微小颗粒骨复合胶原、骨形态发生蛋白(BMP)修复节段性兔桡骨缺损的效果。方法将兔自体或同种异体骨研磨成微小颗粒，分别与BMP及Ⅰ型胶原复合，并采用兔桡骨干1．5cm缺损的动物模型，通过X线、组织学、骨密度、生物力学等检测手段，与自体微小颗粒骨复合胶原修复节段性骨缺损的疗效比较。结果自体或深低温冷冻同种异体微小颗粒骨复合BMP胶原比自体微小颗粒骨复合胶原成骨效果优良，其中复合BMP组在8周即可使骨缺损修复，髓腔通畅，在骨缺损修复各时期，其成骨速度及成骨量均好于未复合BMP组。结论自体或深低温冷冻同种异体微小颗粒骨复合胶原BMP均可有效地修复节段性骨缺损，两种方法促进新骨形成无明显差异，异体微小颗粒骨复合胶原BMP是良好的骨缺损修复材料。     

Unilateral versus bilateral instrumented transforaminal lumbar interbody fusion in two-level degenerative lumbar disorders: a prospective randomised study

Purpose

The aim of this study was to analyse the clinical and radiological outcomes of unilateral versus bilateral instrumented TLIF in two-level degenerative lumbar disorders.

Methods

A prospective randomised clinical study was performed from January 2008 to May 2011. Sixty-eight consecutive patients with severe low back pain and radicular pain were divided randomly into the unilateral (n = 33) or bilateral (n = 35) pedicle screw fixation group based on a random number list. Operative time, blood loss, duration of hospital stay, fusion rate, complication rate and implant costs were recorded and analysed statistically. Visual analog scale (VAS) scores, Oswestry Disability Index (ODI), and SF-36 were used to assess the preoperative and postoperative clinical results in the two groups.

Results

No differences were observed between the two groups with respect to demographic data. The patients of the two groups had significant improvement in functional outcome compared to preoperatively. There was no significant difference comparing fusion rate, complication rate and duration of hospital stay between the two groups at postoperative follow-up (P > 0.05). However, compared with the bilateral pedicle screw group, a significant decrease occurred in operative time, blood loss and implant costs in the unilateral group.

Conclusion

Two-level unilateral instrumented TLIF is an effective and safe method with reduced operative time and blood loss for multiple-level lumbar diseases. But it is imperative that the larger cage should be appropriately positioned to support the contralateral part of the anterior column by crossing the midline of the vertebral body.     

Efficacy comparison of Accell Evo3 and Grafton demineralized bone matrix putties against autologous bone in a rat posterolateral spine fusion model

Background Context

Spinal fusion procedures are intended to stabilize the spinal column for a multitude of disorders including abnormal curvature, traumatic instability, degenerative instability, and damage from infections or tumors. As an aid in the bone healing response, bone graft materials are used to bridge joints for arthrodesis and promote unions in pseudoarthrosis. Currently, the gold standard for stabilizing fusion masses in spinal procedures involves using the osteogenic, osteoinductive, and osteoconductive properties of autologous iliac crest corticocancellous bone. However, considerable morbidity is associated with harvesting the autologous graft. Donor site complications including infection, large hematomas, and pain have been reported at rates as high as 50% (Boden and Jeffrey, 1995). Biologically, the rate of bone repair dictates the rate at which the fusion mass will unite under autologous graft conditions.

Single-level instrumented posterolateral fusion of the lumbar spine with a local bone graft versus an iliac crest bone graft: a prospective, randomized study with a 2-year follow-up

The iliac crest bone grafting (ICBG) technique for lumbar posterolateral fusion surgery is widely used; however, donor site problems such as pain and sensory disturbance have been reported. Local bone is available for fusion surgery, but its reliability as a graft has not been fully reported. In the current study, we examined single-level instrumented posterolateral fusion with a local bone graft versus an ICBG in a prospective randomized study. Eighty-two patients diagnosed with L4 degenerated spondylolisthesis were divided into two groups at random. Forty-two patients underwent instrumented posterolateral fusion with a local bone graft (L4–L5 level), and 40 patients underwent instrumented posterolateral fusion with an ICBG (L4–L5 level). Rate and duration of bone union, visual analog scale (VAS) score, Japanese orthopedic association score (JOAS), Oswestry Disability Index (ODI), and complications were evaluated before and 2 years after therapy. VAS score, JOAS, and ODI were not significantly different between the two groups before and after surgery (P > 0.05). Rate and average duration of bone union were 90% and 8.5 months in the local bone graft group, and 85% and 7.7 months in the ICBG group, but without significant difference (P > 0.05). Prolonged surgical time and complications such as donor site pain (8 patients) and sensory disturbance (6 patients) were observed in the ICBG group. If single-level posterolateral fusion was performed, local bone graft technique has the same bone union rate compared with ICBG, requires less surgical time, and has fewer complications.     

人工骨联合自体骨髓移植技术的骨缺损修复研究与应用

目的分析人工骨联合自体骨髓移植技术治疗骨缺损的临床疗效。方法选取2011年4月至2013年9月,来本院诊治的四肢粉碎性骨折术后骨缺损患者40例,随机分为两组（A、B组）,分别行自体髂骨植骨和人工骨联合自体骨髓移植治疗四肢粉碎性骨折所致骨缺损。术后观察两组骨折愈合时间,骨折愈合率,并发症的发生及骨缺损的修复和功能重建优良率。结果两组均行6～12个月随访,平均（9.14±1.36）月,所有患者植骨术后均无切口感染、发热等并发症。A组15例骨缺损区愈合良好,住院时间平均（19.36±2.54）天,骨折愈合时间平均（5.67±1.52）个月,骨缺损的修复和功能重建评价标准,优12例,良3例,可3例,差2例,优良率75%;B组18例骨缺损区愈合良好,住院时间平均（12.19±1.52）天,骨折愈合时间平均（3.61±1.13）个月,骨缺损的修复和功能重建评价标准,优16例,良2例,可2例,差0例,优良率90%。B组骨缺损治疗效果显著优于A组。结论人工骨联合自体骨髓移植较单纯自体髂骨移植治疗骨缺损更能促进骨痂生长,加速骨折后骨缺损愈合,更加有效地减少住院时间及骨折愈合时间,骨折愈合率更高,骨缺损修复和功能重建效果更加显著。     

腰椎滑脱症后路自体、同种异体混合骨泥植骨效果分析

[目的]选用自体、同种异体冻干骨泥混合,作为腰椎滑脱症(lumbar spondylolisthesis,LS)椎体间植骨材料。并进行随访,以探讨其骨性融合效果。[方法]随机选取LS病例86例,全部病例按照植骨材料的不同分为自体骨泥组、混合骨泥组。采用腰椎后路椎体间植骨融合术(posterior lumbar interbody fusion,PLIF)。随访时间2年2个月~4年3个月,平均2年5个月。在术前、术后第3个月复查时统计患者VAS评分、Oswestry功能障碍指数(ODI,下同),同时参照JOA腰椎部分评分标准行JOA评分。同时在术后第3、12、24个月复查腰椎X线片、腰椎CT,参考Suk法进行椎体融合评价。[结果]自体骨泥组和混合骨泥组的手术时间和术中出血量没有显著差异。JOA评分示自体骨泥组的优良率达96.77%(30/31例),混合骨泥组优良率达93.02%(40/43例)。术后3个月腰椎X线片示腰椎滑脱解剖复位率为83.78%(62/74例)。83.87%(26/29例)的自体骨泥组患者和79.07%(34/43例)的混合骨泥组患者在12个月内达到骨性愈合标准。两组骨性融合效果没有显著差异。[结论]腰椎滑脱症后路自体、同种异体混合骨泥植骨可以达到较高的融合效果,临床应用效果肯定。     

自体红骨髓注射治疗骨不连术后局灶性骨缺损

目的：观察自体红骨髓注射治疗骨不连术后局灶性骨缺损的临床疗效。方法：13例骨不连术后局灶性骨缺损患者,男8例,女5例;年龄15-60岁,平均32．5岁。骨缺损部位：胫骨7例,股骨2例,肱骨4例。采用自体红骨髓注射至骨折断端治疗,自体红骨髓经皮注射每2周1次,共5次,每月复查肢体正侧位X线片。结果：13例全部获得随访,时间6～12个月,平均7．5个月。13例骨缺损完全修复,平均愈合时间4个月。无严重并发症发生。结论：自体红骨髓注射创伤小,疗效明确,并能缩短骨缺损修复时间,有利于促进肢体功能恢复,是治疗骨不连术后局灶性骨缺损的一种好方法。     

Postoperative pain following posterior iliac crest bone graft harvesting in spine surgery: a prospective,randomized trial

Background Context

Postoperative pain at the site of bone graft harvest for posterior spine fusion is reported to occur in 6%–39% of cases. However, the area around the posterior, superior iliac spine is a frequent site of referred pain for many structures. Therefore, many postoperative spine patients may have pain in the vicinity of the posterior iliac crest that may not in fact be caused by bone graft harvesting. The literature may then overestimate the true incidence of postoperative iliac crest pain.

Recombinant human bone morphogenetic protein is a valid alternative to autologous bone graft for long bone non-unions: a systematic review and meta-analysis

ObjectiveTo compare the efficacy of recombinant human bone morphogenetic proteins (rhBMPs) and autologous bone graft (ABG) on the healing of long bone non-union.MethodsA systematic literature search was conducted on PubMed, Web of Science, Cochrane Library, and CNKI up to December 2021. Two authors independently screened the studies, extracted data, and assessed the quality of the trials. A Meta-analysis was performed using state software (version 12.0).ResultsA total of 14 studies were included in this meta-analysis. Overall, there was no significant difference between the rhBMPs group and the ABG group in terms of healing rate (RR = 1.04, 95% CI = 0.96–1.12, p = 0.365) and healing time (SMD = −0.31, 95% CI = −0.76–0.14, p = 0.175). Subgroup analysis showed rhBMPs lead to higher healing rates (RR = 1.35, 95% CI = 1.17–1.56, p < 0.001), and shorter healing time (SMD = −0.65, 95% CI = −1.08 to −0.22, p = 0.003) in the subgroup of moderate-quality studies. Sensitivity analysis proved that our conclusions were relatively robust. No significant publication bias was recognized in all studies (Begg’s test, p = 0.193; Egger's test, p = 0.307).ConclusionsRhBMPs or combined with allografts bone, inorganic bone was a valid alternative to ABG for the treatment of long bone non-union.     

Evaluation of a novel reconstituted bone xenograft using processed bovine cancellous bone in combination with purified bovine bone morphogenetic protein

Long B, Dan L, Jian L, Yunyu H, Shu H, Zhi Y. Evaluation of a novel reconstituted bone xenograft using processed bovine cancellous bone in combination with purified bovine bone morphogenetic protein. Xenotransplantation 2012; 19: 122–132. © 2012 John Wiley & Sons A/S. Abstract: Background: Xenogeneic grafting represents an alternative to autogenous grafting in osseous reconstruction and exhibits many beneficial properties. However, the usefulness of xenogeneic bone relies on necessary processing procedures for removing antigens and viruses, and preserving biological activities simultaneously. By chemical treatment of bovine cancellous bone to make it an antigen‐free scaffold, and extraction of bone morphogenetic protein (BMP) from bovine cortical bone, followed by recombination of the scaffold with the BMP, we developed a new grafting material, reconstituted bone xenograft (RBX). Methods: In this study, scanning electron microscope and energy dispersive X‐ray were first employed to observe the structure and components of RBX. Then the biomechanical property was evaluated by applying compression in a materials testing machine. Subsequently, the immunologic evaluation was performed by measuring galactose‐alpha‐1,3‐galactose (α‐gal) epitope in vivo and proinflammatory cytokine (TNF‐α) secreted by human monocytic cell line (THP‐1) in vitro. Finally, this RBX was implanted into segmental radial defects in a rabbit model, and its ability to treat large bone defects was specifically evaluated. Results: Although the compressive strength of RBX was 10% lower than that of unprocessed bovine cancellous bone (UBCB), the basic porous structure and natural components were still kept in this composite. The α‐gal xenoantigen level was significantly lower in RBX (P < 0.05) compared with UBCB. Moreover, the TNF‐α level was significantly (P < 0.05) reduced compared with UBCB when THP‐1 was exposed to RBX. On the other hand, RBX appeared to induce cartilage formation from immature cell populations and resulted in osteogenesis through endochondral‐like ossification from 4 to 12 weeks in repairing segmental bone defects. Conclusions: These results demonstrate that RBX, with its natural microstructure and components, certain mechanical strength and strong osteoinductivity without evoking immune rejection, has significant potential for the treatment of bone defects.     

Gerdy's tubercle as a source of cancellous bone graft for surgery of the upper extremity: description of technique

Cancellous bone grafts can be harvested from Gerdy's tubercle on the proximal metaphysis of the tibia for surgical procedures on the upper extremity. This donor site, however, is used rarely by hand surgeons, possibly because of a lack of awareness.     

Use of an autologous cortical bone graft sandwiched between two intervertebral spacers in posterior lumbar interbody fusion

Various intervertebral spacers with or without posterior instrumentation use pedicle screw fixation in posterior lumbar interbody fusion (PLIF). Recently we harvested an autologous cortical bone graft from a spinous process by en bloc resection and inserted it between two intervertebral spacers during PLIF surgery. Due to better balance, this procedure provides greater mechanical strength, larger contact area, and better bilateral restoration of disc height than PLIF using intervertebral spacers only, and there is no need to take a bone graft from the iliac crest. This technique appears to result in effective spinal fusion in PLIF surgery. Received: 19 September 2000 / Accepted: 15 November 2000     

Fibula and tibia fusion with cancellous allograft vitalised with autologous bone marrow: first results for infected tibial non-union

Background and aims  Autogenous bone grafting has been used in reconstructing bone defects and in stimulating fracture healing, producing high healing rates in the treatment of infected tibial non-unions. A novel therapeutic alternative is now available known as “vitalised allograft”, a cancellous bone graft procured from femoral heads from living human donors and “vitalised” through the injection of autologous bone marrow. The aim of this study is to summarise the initial results of the fibula and tibia fusion using vitalised cancellous allograft in the treatment of infected tibial non-unions. Patients and methods  We initiated a follow-up of 15 prospective non-randomized patients who received a vitalised allograft in the treatment of infected tibial non-unions in order to produce bony union. The patients included 13 men and 2 women with an average age of 48 years. All patients received a multi-stage surgical approach. After establishing an infection-free environment, allogenic cancellous bone grafting was performed, intended as the final surgical procedure in fibula and tibia fusion. Our follow-up included a clinical and radiographic investigation of the calf in four planes. We analysed union-rate and time required for bony consolidation, as well as recurrent infections, re-fractures, potential graft-resorption, and time needed for graft and bone remodelling. Results  With an average follow-up of 17.1 months, infection control was obtained in 14 of 15 patients, producing an infection arrest rate of 93.3%. Radiographs indicated consolidation in 11 out of 15 cases, with a union rate of 73.3%. Bone union was achieved on average in 17.1 weeks. Conclusions  Fibula and tibia fusion with allogenic cancellous bone grafting, vitalised through autogenic bone marrow, could well become an innovative treatment option for infected tibial non-unions. We need, however, to analyse a higher number of cases over a longer follow-up period in order to assess more accurately recurrent infections and re-fractures.     

Thoracolumbar spinal fractures: segmental range of motion after dorsal spondylodesis in 82 patients: a prospective study

In order to study the effect of dorsal spondylodesis on intervertebral movement in patients treated for thoracolumbar fractures, we measured the sagittal range of motion (ROM) in the segments above and below the fractured vertebral body 2 years after operation. Between 1991 and 1996, 82 consecutive patients with a fracture of the thoracolumbar spine (T12, L1, L2 and L3) were treated operatively with open reduction and stabilisation using an internal fixator, combined with transpedicular cancellous bone graft and dorsal spondylodesis. Eighteen T12, 42 L1, 17 L2 and 5 L3 fractures were included. The range of motion of two segments above and two segments below fracture level was measured. This was done on plain flexion and extension radiographs. The data were compared to normal values and to the zero distribution with the Kolmogorov-Smimov test. At all fracture levels the ROM of the segment adjacent to the disturbed endplate of the fractured body was zero (K-S test). All other evaluated segments showed significant loss of ROM (P<0.05) compared to normal values, except segment L1-L2 in L3 fractures (P=0.058). Dorsal spondylodesis at the level of the disturbed endplate in thoracolumbar spinal fractures leads to immobility in this segment, measured on flexion-extension radiographs 2 years after primary operative treatment. More than 50% loss of motion in the two adjacent levels is equivalent to complete loss of ROM in a second segment.     

Use of demineralized bone matrix in spinal fusion

Spinal fusion remains the gold-standard treatment for several pathological spine conditions. Although, autologous Iliac Crest Bone Grafting is considered the gold-standard graft choice to promote spinal fusion; however, it is associated with significant donor site morbidity and a limited graft quantity. Therefore, several bone graft alternatives have been developed, to augment arthrodesis. The purpose of this review is to present the results of clinical studies concerning the use of demineralized bone matrix (DBM), alone or as a composite graft, in the spinal fusion. A critical review of the English-language literature was conducted on Pubmed, using key word “demineralized bone matrix”, “DBM”, “spinal fusion”, and “scoliosis”. Results had been restricted to clinical studies. The majority of clinical trials demonstrate satisfactory fusion rates when DBM is employed as a graft extender or a graft enhancer. Limited number of prospective randomized controlled trials (4 studies), have been performed comparing DBM to autologous iliac crest bone graft in spine fusion. The majority of the clinical trials demonstrate comparable efficacy of DBM when it used as a graft extender in combination with autograft, but there is no clinical evidence to support its use as a standalone graft material. Additionally, high level of evidence studies are required, in order to optimize and clarify the indications of its use and the appropriate patient population that will benefit from DBM in spine arthrodesis.     

Posterolateral lumbar spine fusion using a novel demineralized bone matrix: a controlled case pilot study

Introduction

Intertransverse posterolateral fusion along with instrumentation is a common technique used for spinal fusion. Iliac crest bone graft (ICBG) offers good fusion success rates with a low risk for disease transmission but is, however, linked with certain morbidity. In an effort to eliminate or reduce the amount of iliac graft needed, bone substitutes including demineralized bone matrix (DBM) have been developed. This study evaluates a novel DBM (Accell Connexus^®) used in one or two-level instrumented posterolateral lumbar fusion.

Materials and methods

A total of 59 consecutive patients were studied as two groups. Group 1 consisted of 33 patients having Accell Connexus^® used to augment either ICBG or local decompression material. Group 2 consisted of 26 consecutive patients, operated prior to the introduction of this novel DBM, having either ICBG alone or local decompression material. Fusion was assessed by two independent observers, blinded to graft material, using standardized criteria found in the literature. All adverse events were recorded prospectively.

Results

The results show no statistically significant differences between the two groups in fusion rates, complications, surgery duration, ODI, or pain on VAS. Logistical regression showed no relation between fusion and age, smoking status or comorbidities. Furthermore, no adverse events related to the use of the novel DBM were observed.

Conclusion

The results from this study demonstrate that the novel DBM presented performs equally as well as that of autologous bone, be it either ICBG or a local decompression material, and can therefore be used as a graft extender.

     

Symptomatic calcified perineural cyst after use of bone morphogenetic protein in transforaminal lumbar interbody fusion: a case report

Background contextHuman recombinant bone morphogenetic protein-2 (BMP-2) is commonly used in spinal surgery to augment arthrodesis, and a number of potential complications have been documented.PurposeTo present the case of a delayed radiculopathy that occurred because of a calcified perineural cyst that formed after an L4–L5 transforaminal lumbar interbody fusion (TLIF) in which BMP-2 was used.Study design/settingCase report of a 70-year-old man presented with back and right lower extremity pain.MethodsA 70-year-old man who had previously undergone a right L4–L5 TLIF presented 20 months after surgery with progressively radiating right leg pain. Imaging revealed a right-sided L4–L5 cystic lesion posterior to the interbody cage. The patient underwent reexploration, and a calcified mass was discovered.ResultsHistopathology revealed fragments of organized collagenous connective tissue, new collagen, and partially calcified fragments of fibrocartilage, bone, and ligament.ConclusionsThis is the first reported case of a symptomatic calcified perineural cyst developing after a fusion procedure in which BMP-2 was used. The presence of connective tissue with metaplastic bone formation and maturation within the lesion suggests that formation of the cyst was secondary to application of BMP-2, as it possesses both osteogenic and chondrogenic capabilities.