解剖锁定钢板联合锚钉治疗NeerⅡb型锁骨远端粉碎骨折

目的探讨解剖锁定钢板联合锚钉治疗NeerⅡb型锁骨远端粉碎骨折的疗效。方法采用解剖锁定钢板联合锚钉治疗18例NeerⅡb型锁骨远端粉碎骨折患者。末次随访采用Constant-Murley评分标准进行肩关节功能评定。结果患者均获得随访,时间10~27个月。1例术后发生浅表切口感染,经换药及口服抗生素后愈合;其余17例均无切口感染、骨折延迟愈合、内固定松动、断裂及继发骨折等并发症发生。骨折全部愈合,时间10~20周。末次随访时,喙锁间距患侧与健侧比较差异无统计学意义(P>0.05);Constant-Murley评分为81~98分,其中优14例,良4例。结论解剖锁定钢板联合锚钉治疗NeerⅡb型锁骨远端粉碎骨折,可获得接近解剖的喙锁间距及良好的肩关节功能,且骨折愈合快、并发症少。     

单独锁定钢板和锁定钢板联合缝合锚治疗不稳定型锁骨远端骨折的病例对照研究

目的:比较单独锁骨远端解剖锁定钢板和解剖锁定钢板联合缝合锚治疗NeerⅡb锁骨远端骨折的临床疗效。方法:回顾性分析2013年1月至2015年1月收治的40例NeerⅡb型锁骨远端骨折患者的临床资料,根据手术方法的不同分为锁骨远端解剖锁定钢板联合缝合锚钉组(观察组)和单纯锁骨远端解剖锁定钢板组(对照组)。观察组20例,采用解剖锁定钢板联合缝合锚进行喙锁韧带重建治疗,其中男15例,女5例,年龄20～57(37.30±10.56)岁。对照组20例,采用单纯解剖锁定钢板固定,其中男16例,女4例,年龄26～64 (40.60±12.64)岁。比较两组患者的手术切口长度、手术时间、出血量和住院时间,拍摄X线片观察骨折愈合情况、内固定位置以及喙锁间距变化,并采用ConstantMurley评分评定肩关节功能。结果:两组患者均获得随访,时间24～42(30.08±6.72)个月。两组患者在切口长度、手术时间、出血量、住院时间和骨折愈合时间方面比较差异无统计学意义(P0.05)。末次随访时对照组Constant-Murley评分为(83.10±5.81)分,低于观察组(92.30±6.05)分(P0.05);对照组喙锁间距(11.22±3.85) mm,大于观察组(8.71±2.14) mm(P0.05)。结论:解剖锁定钢板联合缝合锚治疗NeerⅡb型锁骨远端骨折比单纯解剖锁定钢板具有更好的肩关节功能和更小的喙锁间距,说明喙锁韧带加强是治疗NeerⅡb型锁骨远端骨折一种有效的补充方法。     

解剖锁定钢板内固定联合喙锁韧带重建治疗Neer Ⅱb型锁骨远端骨折的疗效研究

目的通过与单纯解剖锁定钢板治疗比较,探讨解剖锁定钢板内固定联合喙锁韧带重建治疗NeerⅡb型锁骨远端骨折的临床疗效。方法回顾分析2013年2月—2017年1月收治并符合选择标准的40例NeerⅡb型锁骨远端骨折患者临床资料,其中18例采用解剖锁定钢板内固定联合1枚锚钉重建喙锁韧带治疗(重建组),22例采用单纯解剖锁定钢板内固定治疗(非重建组)。两组患者性别、年龄、受伤侧别、致伤原因、合并伤、受伤至手术时间等一般资料比较,差异均无统计学意义(P0.05),具有可比性。记录并比较两组手术时间、医疗费用以及术后患侧喙锁间距、肩关节Constant-Murley评分、并发症发生情况。结果两组患者均获随访,随访时间12～27个月,平均16.3个月。重建组1例术后发生切口浅表感染,非重建组1例术后1个月发生钢板螺钉从远端骨块中拔出伴复位丢失。重建组手术时间及医疗费用均较非重建组明显增加(P0.05)。末次随访时,骨折均达骨性愈合,重建组患侧喙锁间距增加率明显低于非重建组(t=2.371,P=0.023)。术前及术后1、3个月及末次随访时,两组Constant-Murley评分比较差异均无统计学意义(P0.05);但组内术后各时间点评分均高于术前,差异均有统计学意义(P0.05)。结论对于NeerⅡb型锁骨远端骨折,无论是否行喙锁韧带重建,采用解剖锁定钢板内固定后均能获得良好疗效。因此,除远端骨块小于1 cm的粉碎性骨折或依从性较差者外,无需常规重建喙锁韧带。     

解剖锁定钢板联合线缆重建喙锁韧带治疗锁骨骨折的研究

目的观察解剖锁定钢板联合线缆重建喙锁韧带用于治疗锁骨远端不稳定骨折的临床疗效。方法以126例NeerⅡ型锁骨远端骨折患者为研究对象,按随机数字表法分为对照组(63例)和研究组(63例),对照组实施锁骨钩钢板固定术,研究组实施解剖锁定钢板联合线缆重建喙锁韧带术,比较两组手术指标差异,评价术后肩关节功能,观察术后并发症情况。结果两组术中出血量、手术操作耗时、切口长度、住院时间、切口愈合时间和骨折创面愈合时间差异均不具有统计学意义(P0.05);研究组术后1年肩关节Constant-Murley疼痛、功能、活动度、肌力各单项评分和总分均显著高于对照组水平(P0.05);研究组术后并发症发生率(4.76%)显著低于对照组水平(17.46%)(P0.05)。结论解剖锁定钢板联合线缆重建喙锁韧带可有效改善锁骨远端不稳定骨折患者肩关节功能,减少术后并发症。     

喙锁固定结合锁骨远端解剖锁定钢板治疗NeerⅡ型锁骨远端骨折

目的探讨应用喙锁固定结合锁骨远端解剖锁定钢板治疗NeerⅡ型锁骨远端骨折的方法及疗效。方法回顾性分析2010年6月-2017年3月收治的26例NeerⅡ型锁骨远端骨折患者采用喙锁固定结合锁骨远端解剖锁定钢板治疗,采用Constant评分标准评定肩关节功能,复查肩关节X线片,观察骨折愈合、并发症情况。结果术后24例获随访,随访时间10～18个月,平均14个月。患者的切口均Ⅰ期愈合。复查X线片示骨折均愈合,愈合时间12～16周,平均14周。随访期间无骨折移位、内固定物断裂、失效等情况发生。最终随访时Constant肩关节功能评分为82～96分,平均92分。结论应用喙锁固定可增强喙锁稳定性,结合锁骨远端解剖锁定钢板固定,术后早期可进行功能康复训练,疗效满意,是治疗不稳定NeerⅡ型锁骨远端骨折的一种有效方法。     

锁定钢板联合克氏针内固定治疗NeerⅡB型锁骨远端骨折的临床疗效

目的探讨锁定钢板联合克氏针内固定治疗NeerⅡB型锁骨远端骨折的临床疗效。方法回顾性分析自2017-01—2020-10采用锁定钢板联合克氏针内固定治疗的36例NeerⅡB型锁骨远端骨折,沿锁骨表面作横弧形切口,自喙突内侧约2 cm至肩锁关节处。显露锁骨远端,切开部分三角肌止点并探查喙锁韧带损伤情况,骨折解剖复位后,用1枚克氏针固定骨折远近端,再于锁骨上方置入锁骨远端锁定解剖钢板。喙锁韧带断裂以1号可吸收线缝合。结果 36例均顺利完成手术并获得完整随访,随访时间3～25个月,平均10.0个月。未出现切口感染、退钉、肩部疼痛及骨折延迟愈合等并发症。手术时间41.0～72.0 min,平均50.3 min。术中出血量70～125 mL,平均95.0 mL。骨折愈合时间8.2～11.5周,平均8.6周。末次随访时Constant-Muley肩关节功能评分88.0～96.0分,平均93.5分;按Constant-Muley肩关节功能评分评价疗效:优28例,良5例,可3例。结论锁定钢板联合克氏针内固定治疗NeerⅡB型锁骨远端骨折手术操作简便,疗效满意,术后并发症较少,值得在临床推广。     

带线锚钉与锁骨钩板内固定治疗Neer Ⅱ型锁骨远端骨折的疗效比较

目的比较分析带线锚钉与锁骨钩板内固定治疗NeerⅡ型锁骨远端骨折的临床疗效。方法回顾性分析自2010-03—2013-12采用Revo软组织带线锚钉(带线锚钉组,20例)和锁骨钩板(锁骨钩板组,20例)内固定治疗的40例NeerⅡ型锁骨远端骨折。比较2组术后并发症发生情况及Karlsson肩关节功能。结果 40例术后获得随访12~18(12.2±1.0)个月。带线锚钉组术后1例出现肩关节疼痛并发症,无内固定失败、肩关节僵硬及骨折延迟愈合发生。锁骨钩板组术后2例骨折延迟愈合,3例肩关节僵硬,3例肩关节疼痛。带线锚钉组术后并发症发生率明显低于锁骨钩板组,差异有统计学意义(P0.05)。带线锚钉组肩关节功能优良率95%,锁骨钩板组优良率70%;带线锚钉组术后肩关节功能优良率明显高于锁骨钩板组,差异有统计学意义(P0.05)。结论 Revo软组织带线锚钉内固定治疗锁骨远端骨折较锁骨钩板内固定可取得更好的临床疗效,术后并发症少,可早期功能锻炼,肩关节功能恢复好。     

锁定钢板联合钛缆治疗NeerⅡb型锁骨远端骨折

目的探讨应用解剖锁定钢板联合钛缆修补喙锁韧带治疗NeerⅡb型锁骨远端骨折的临床疗效。方法回顾性分析上海长征医院2013年1月至2016年2月期间治疗的以NeerⅡb型锁骨远端骨折为分型的病例,共15例,男10例,女5例;年龄42~65岁,平均54岁。均采取手术治疗,选择解剖锁定钢板联合钛缆修补喙锁韧带进行内固定。肩关节评分采用Herscovici疗效评定标准。结果 15例患者均获得完整随访,随访时间6~24个月,平均12个月。末次随访时Herscovici疗效评定优良率为86.67%,其中优8例,良5例,可1例,差1例。所有患者末次随访时X线片显示均获骨性愈合,愈合时间为3~6个月,平均4.8个月。术后无伤口感染、内固定失效、骨折不愈合等并发症。结论解剖锁定钢板联合钛缆修补喙锁韧带治疗NeerⅡb型锁骨远端骨折,可使骨折获得牢固固定,对喙锁韧带的修复效果满意,有利于骨折早期愈合,术后肩关节功能恢复好,无不良并发症,值得临床推广应用。     

锁定钢板治疗锁骨远端Neer Ⅱb型骨折的疗效分析

[目的]探讨锁骨远端锁定加压钢板内固定方法治疗NeerⅡb型锁骨远端骨折的临床疗效。[方法]回顾性分析2012年3月~2013年8月采用锁骨远端前外侧lateral compression plate(LCP)治疗15例NeerⅡb型锁骨远端骨折的资料,男9例,女6例;年龄22~64岁,平均42.1岁;左侧5例,右侧10例。采用锁骨上方横行切口,复位骨折后使用锁定钢板内固定,对于钢板固定后肩锁关节仍不稳定的,采用喙突置入带线锚钉修复喙锁韧带。术后定期摄X线片,采用Constant、SF-36评分系统分别对术后肩关节功能及全身功能进行评定。[结果]15例锁骨远端骨折患者均获随访,随访时间14~26个月,平均20.5个月。X线片显示锁骨骨折均在4~6个月内愈合,平均骨折愈合时间4.5个月。Constant肩关节功能评分,优11例,良4例,优良率100%。与健侧肩关节的功能评分接近。SF-36评分为85.5~100分,平均94.6分。末次随访时,无1例发生钢板断裂、钢板周围骨折和肩袖损伤等并发症。[结论]切开复位锁骨远端锁定加压钢板内固定方法治疗NeerⅡb型锁骨远端骨折能取得良好的临床疗效,具有肩关节功能恢复好、并发症少等优点,是治疗锁骨远端骨折较好的内固定方法。     

不修复韧带的解剖型锁定钢板治疗锁骨远端Neer Ⅱ型骨折

目的：探讨应用解剖型锁定钢板治疗NeerⅡ锁骨远端骨折的临床疗效。方法回顾性分析2012年1月至2014年6月间收治的9例NeerⅡ锁骨远端骨折患者的临床资料。其中男6例,女3例;年龄为21~61岁,平均43岁。术中所有患者均未修复喙锁韧带,应用解剖型锁定钢板内固定治疗骨折。术后定期X线检查明确骨折愈合情况,按照Neer评分标准进行肩关节功能评分。结果患者手术均顺利完成,术中无血管神经损伤,无感染、骨折不愈合等并发症发生。本组9例患者均获得随访,随访时间为6~18个月,平均12个月。骨折全部愈合,愈合时间为10~16周,平均12周。末次随访根据Neer肩关节功能评分：优5例,良3例,可1例。结论锁骨远端解剖锁定钢板内固定是治疗NeerⅡ型锁骨远端骨折的有效方法,术后肩关节疼痛及活动受限发生率低,有利于早期功能锻炼。     

钩钢板和解剖锁定板治疗锁骨远端NeerⅡ型骨折的疗效比较

目的比较解剖锁定板和钩钢板治疗锁骨远端NearⅡ型骨折的疗效。方法对32例锁骨远端NeerⅡ型骨折患者分别采用解剖锁定板固定(18例)和钩钢板固定(14例)。结果患者均获得随访,时间9~20个月。患者骨折均愈合,无伤口感染、内固定失效等并发症发生。钩钢板组出现2例肩关节疼痛、外展受限,3例肩峰下骨侵蚀,于术后6~8个月取出内固定物,肩关节疼痛逐渐缓解,功能恢复良好。术后3、6个月解剖锁定板组肩关节功能优于钩钢板组(P0.01),内固定物取出后3个月,两组肩关节功能比较差异无统计学意义(P0.05)。结论解剖锁定板和钩钢板都是治疗锁骨远端NeerⅡ型骨折的有效方法,应根据不同的骨折选择合适的内固定物。     

带袢钢板重建喙锁韧带与锁骨钩钢板治疗 锁骨远端骨折的病例对照研究

目的：探讨带袢钢板加爱惜帮缝线双束重建喙锁韧带和锁骨钩钢板治疗NeerⅡ型锁骨远端骨折的疗效差异。方法：2008年11月至2009年12月,采用带袢钢板加爱惜帮缝线双束重建喙锁韧带（A组8例）和锁骨钩钢板（B组10例）治疗18例锁骨远端骨折患者,其中男10例,女8例,年龄28～65岁,平均38岁。所有损伤均为新鲜损伤,X线表现为NeerⅡ型锁骨远端骨折,损伤至手术时间为2～5d,平均2.8d。所有患者受伤前肩关节活动均正常。术后第1、2、3个月对患肩功能用Constant Murley评分系统进行评分。结果：两组患者切口均Ⅰ期愈合,无感染发生,无臂丛神经损伤。X线提示,所有骨折在术后3个月时有连续骨小梁通过,证实骨折愈合。所有患者均获得随访,时间3～8个月,平均5.7个月。术后第1、2、3个月,A组Constant Murley评分分值分别为：（91.4±6.7）、（97.5±2.6）、（98.3±2.0）分;B组分别为：（70.1±5.1）、（89.0±7.6）、（94.2±4.6）分。在术后1、2、3个月,A组的肩关节评分均高于B组,差异具有统计学意义（P〈0.05）。结论：带袢钢板加爱惜帮缝线双束重建喙锁韧带治疗NeerⅡ型锁骨远端骨折,由于不影响肩锁关节,患者可以获得更好的肩关节功能,虽然这一固定方式是非坚强固定,但是所有骨折均愈合。这一技术的应用有赖于完整和坚强的喙突,在小喙突和骨质疏松的患者中可能不适用。     

缝合锚技术治疗肩锁关节脱位的功能生物力学研究

目的 探讨缝合锚技术治疗肩锁关节脱位的功能生物力学研究.方法 采用4具新鲜尸体肩关节标本.分别测定正常喙锁韧带、缝合锚、锁骨钩钢板固定的生物力学性能.结果 缝合锚技术在单轴拉伸试验的位移应变和断裂能比正常喙锁韧带及锁骨钩钢板增强,有一定优势,经统计学处理显示有显著性差异(P<0.05).结论 缝合锚技术在强度、刚度、稳定性方面占有优势,具有较多的生物学和力学上的优越性,临床上有较好的应用前景.     

锁定钢板与钩钢板治疗NeerⅡ型锁骨远端骨折对比

[目的]对比锁骨远端锁定钢板与锁骨钩钢板治疗NeerⅡ型锁骨远端骨折的临床疗效。[方法]回顾2014年9月~2017年8月在本科接受手术治疗的NeerⅡ型锁骨远端骨折患者共46例,根据手术方式不同分为两组,锁定钢板组22例,锁骨钩钢板组24例。比较两组患者在手术时间、术中出血量、手术切口长度、骨折愈合情况、术后疼痛、术后并发症及术后肩关节功能方面的差异。疼痛评估采用视觉模拟评分(VAS),肩关节功能评价使用Con⁃stant-Murley评分和UCLA评分。[结果]两组在手术时间、术中出血量方面比较差异无统计学意义(P>0.05),但锁定钢板组手术切口长度显著短于锁骨钩钢板组(P<0.05)。随访时间至少为12个月。两组患者骨折均完全愈合,且骨折临床愈合时间差异无统计学意义(P>0.05)。术后3个月时,锁定钢板组的VAS评分、Constant-Murley评分和UCLA评分均显著优于钩钢板组(P<0.05);但术后6个月时,两组间上述评分的差异均无统计学意义(P>0.05)。锁定钢板组后期并发症2例,而钩钢板组9例,两组间差异有统计学意义(P<0.05)。[结论]与锁骨钩钢板相比,使用锁骨远端锁定钢板治疗NeerⅡ型锁骨远端骨折切口更小,可明显减少术后短期疼痛及术后并发症发生率。     

锁定加压钢板治疗锁骨远端Neer IIB 型骨折

 目的 探讨采用锁骨远端前外侧锁定加压钢板(locking compression plate, LCP)治疗锁骨远端Neer IIB 型骨折的疗效。方法 回顾性分析2009 年1 月至2010 年10 月采用锁骨远端前外侧LCP治疗11 例Neer IIB 型锁骨远端骨折的资料, 男9 例, 女2 例;年龄23~43 岁, 平均37.2 岁;左侧5例, 右侧6例;损伤至手术时间为24~72 h, 平均48 h。骨折复位后将LCP 置于锁骨远端上方, 首先采用锁定螺钉固定锁骨远端, 可根据骨折的长度选择3~6枚2.5 mm 的锁定螺钉, 然后用3.5 mm锁定螺钉固定骨折近端, 无需修复喙锁韧带。采用美国肩肘外科医师学会(American Shoulder and Elbow Surgeons, ASES)评分评价术后肩关节功能。结果 11 例患者均获得随访, 随访时间为9~12 个月, 平均10.3 个月。X 线片示锁骨骨折均愈合, 其中10 例在术后6 个月内骨折愈合, 1 例在术后9 个月骨折愈合。11 例患者ASES 评分为84~91 分, 平均89.1 分, 与健侧肩关节的功能评分相近。末次随访时, 无一例发生钢板断裂、钢板周围骨折和肩袖损伤等并发症。结论 采用锁骨远端前外侧LCP治疗Neer IIB 型锁骨远端骨 折可以稳定锁骨远端, 避免骨折不愈合和经肩关节固定锁骨远端的并发症。     

Treatment of unstable distal clavicle fractures using two suture anchors and suture tension bands

Objective

The study presents a surgical technique using two suture anchors combined with two non-absorbable suture tension bands and the clinical and radiological results obtained in patients with acute distal clavicle fractures associated with coracoclavicular ligaments disruption.

Materials and methods

Nineteen patients with distal clavicle fractures were included with a mean follow-up of 25 months. All patients had type IIb fractures according to the Neer classification. Coracoclavicular ligaments were reconstructed using two suture anchors to maintain distal clavicle in an anatomical position, and supplementary interfragmentary fixation was performed using two non-absorbable suture tension bands in figure-of-eight configurations. Functional outcomes were assessed at final follow-up visits using the Constant score.

Results

The numbers of lateral fragments averaged 1.4. Seventeen patients maintained the same vertical coracoclavicular distance between both shoulders. However, in two patients, the coracoclavicular distance of the injured shoulder increased by 50% compared with that of the contralateral shoulder. Fracture union was obtained in 18 patients at a mean 4.8 months postoperatively. One patient had symptomatic nonunion until 9 months postoperatively, and subsequently, distal clavicle resection was performed. Two patients showed delayed union and achieved fracture union at 9 and 10 months postoperatively, respectively. Clavicular erosion was found in two patients. The lateral fragment of one patient united in an upward angulated position caused by over-tightening of the medial clavicle. The average Constant score improved to 94.

Conclusion

Coracoclavicular reconstruction using two suture anchors and supplementary interfragmentary fixation using two non-absorbable suture tension bands for acute distal clavicle fracture are reliable techniques for restoring stability in patients with acute distal clavicle fracture.     

Treatment of acute unstable distal clavicle fractures with single coracoclavicular suture fixation

Distal clavicular fractures are less common than fractures involving the middle third of the clavicle. For Neer type IIb distal clavicular unstable fractures associated with disruption of the coracoclavicular ligament, surgical treatment is indicated because of the high risk of nonunion. Various surgical methods can be found in the literature, but no gold standard has been established. We treated 29 consecutive adult patients with unstable distal clavicular fracture with single coracoclavicular suture fixation by using single Mersilene tape (Ethicon, Somerville, New Jersey) and without repair of the torn coracoclavicular ligament or hardware implantation.Twenty-eight patients were followed for at least 46 months (mean, 57.3 months). All fractures healed without further treatment, with a mean time to union of 14.3 weeks. There was no major morbidity, but 2 minor complications occurred. One patient experienced a frozen shoulder on the treated side postoperatively. After adequate rehabilitation, the symptom resolved without any complications at final follow-up. Another patient reported uncomfortable skin tenting due to subcutaneous protrusion of the suture node of the Mersilene tape. After simple subcutaneous surgical removal of the node under local anesthesia, the discomfort resolved. Mean University of California Los Angeles shoulder rating score was 34 (range, 29-35). Twenty patients had excellent results and 8 had good results. All patients resumed their previous levels of activity.     

Precontoured Locking Compression Plate with Titanium Alloy Cable System: In Treatment of Neer Type IIb Distal Clavicle Fracture

ObjectiveTo describe a new method which involves anatomical distal clavicle plate fixation and titanium alloy cable system‐augmented coracoclavicular ligament reconstruction to manage Neer type IIb distal clavicle fracture.MethodsBetween January 2013 and June 2018, 28 patients with acute Neer type IIb lateral clavicle fracture were treated by a new method – precontoured locking compressive distal clavicular plate fixation of the fracture combined with titanium alloy cable system‐augmented reconstruction of the coracoclavicular ligament. There were 11 females and 17 males treated in this way. There were 15 cases of the right side and 13 of the left. The mean age of the patients was 48.5 years (range, 18–78 years). The mean time from injury to surgery was 3.9 days (range, 1–7 days). After completing the preoperative examinations and evaluations, surgeries were performed for all these patients, anatomical distal clavicle plates were used for fractures, and titanium alloy cables were implanted for the augmented reconstruction of coracoclavicular ligaments. Postoperative protocols, including arm sling management and rehabilitative activities, were unified and recommended to all the patients. These patients were followed up for at least 1 year. The mean duration of postoperative follow‐up was 23.3 months (range, 12–52 months). At the last follow‐up, the coracoclavicular distances were recorded and shoulder functional outcomes were assessed by the Constant scores and the Fudan University Shoulder Scores (FUSSs) questionnaires.ResultsRadiographic bony unions were achieved in all patients within 20 weeks. Functional and radiographic outcomes were retrospectively evaluated. The mean coracoclavicular distance was 9.61 ± 0.61 mm on the injured side vs 9.62 ± 0.57 mm on the contralateral uninjured side. The mean Constant score and mean FUSS were 90.1 ± 6.6 (range, 68–98) and 86.1 ± 7.2 (range, 64–95) respectively, which indicating good restoration of function and high level of satisfaction for both the patients and their physical therapists. There were a few major complications, including one delayed healing of the skin, one severe shoulder stiffness, three incidences of moderate shoulder stiffness, and five incidences of symptomatic hardware. There is no deep infections, neurovascular injuried, delayed union or nonunion, peri‐implant fracture, loss of reduction, implant malposition or failure, or other severe complications.ConclusionThis combined method for the treatment of Neer type IIb distal clavicle fracture could yield high bony union rate, good functional outcome, and low complication rate. Further prospective randomized controlled studies are needed to confirm the benefits of this method of treatment.