A prospective randomized comparison of bioabsorbable and titanium anterior cruciate ligament interference screws
A prospective randomized comparison of bioabsorbable and titanium anterior cruciate ligament interference screws
复制标题
DOI：
10.1016/j.arthro.2004.09.012
复制
发表时间：
2005-02-01
影响因子：
4.7
通讯作者：
Pedroza, A
中科院分区：
文献类型：
--
作者：
Kaeding, C;Farr, J;Pedroza, A
目的：比较Phantom生物可吸收聚合物干扰螺钉(DePuy，Warsaw，IN)和钛金属干扰螺钉在自体骨-髌腱-骨移植重建前交叉韧带(ACL)重建股骨和胫骨中段骨块中的应用。研究类型：多中心前瞻性随机研究。方法：两位外科医生在不同的位置进行初次前交叉韧带重建。手术前，患者被随机分配。一组接受钛空心干扰螺钉。第二组采用中空聚L乳酸生物可吸收螺纹钉。数据包括活动水平的主观评估和国际膝关节文件委员会的评分。客观测量采用KT-1000型关节测量仪(MedMetric，加利福尼亚州圣地亚哥)，测量患者术中或术后的活动度、积液情况和并发症。测量时间分别为1岁和2岁。放射学评估从最初的手术日期开始至少两年，并由两名独立的骨科医生解释。结果：在1年的随访期(N=97)，幻影螺丝钉组(6)在中度活动时疼痛的报告比钛钉组(0)更多(P=0.03)。活动范围(P=.45)、活动程度(P=.83)、活动肿胀(P=.95)、部分活动(P=.13)或完全活动(P=.31)之间无统计学差异。膝关节积液(P=.33)或KT-1000两侧差异(P=.53)。在2年的随访中(N=65)，幻影干扰螺丝钉组中更多的受试者(18)报告了剧烈类别的活动水平，与钛干扰螺丝钉组(7)中的受试者相比(P=0.02)。在疼痛(P=.97)、积液(P=.17)、部分(P=.28)或完全(P=.27)退让、肿胀伴活动度(P=.21)、活动范围(P=.64)或KT-1000左右差异(P=.96)方面没有差异。放射学检查显示，可吸收材料引起的骨塞位置、骨溶解、不良反应或并发症均未见改变。在两组中都看到了隧道加宽的一些证据。结论：在前交叉韧带重建中，使用聚L-乳酸生物可吸收干扰螺钉可获得与金属干扰螺钉固定中央三分之一骨-髌腱-骨的临床效果相同的临床效果。
Purpose: To compare the Phantom bioabsorbable polymer interference screw (DePuy, Warsaw, IN) with a titanium metal interference screw when used in fixation of femoral and tibial bone blocks in central third bone-patellar tendon-bone autograft anterior cruciate ligament (ACL) reconstructions. Type of Study: Multicentered prospective randomized Study. Methods: Two surgeons performed primary ACL reconstructions at different locations. Preoperatively, the patients were randomly assigned. One Group received a titanium cannulated interference screw. The second group received the cannulated poly-L-lactic bioabsorbable Phantom screw. Data included Subjective evaluation of activity level and International Knee Documentation Committee scores. Objective measures were made Using the KT-1000 arthrometer (MedMetric, San Diego, CA), range of motion, presence of effusions, and complications intraoperatively or postoperatively. Measurements were made Lit 1 year and 2 years. Radiographic evaluation was carried out at least 2 years from the initial surgical date and interpreted by 2 independent orthopaedic surgeons. Results: At the 1-year follow-up (N = 97), pain was reported more during moderate activity in the Phantom screw group (6) compared with the titanium screw Group (0) (P = .03). No statistical difference between range of motion (P = .45), activity level (P = .83), swelling with activity (P = .95), partial (P = .13) or full (P = .31) giving way. knee effusions (P = .33), or KT-1000 side-to-side difference (P = .53) were found. At the 2-year follow-up (N = 65), more subjects (18) in the Phantom interference screw Group reported activity levels in the strenuous category compared with those in the titanium interference screws (7) Group (P = .02). No differences were reported with respect to pain (P = .97), effusion (P = .17) partial (P = .28) or full (P = .27) giving way, swelling with activity (P = .21), range of motion (P = .64), or KT-1000 side-to-side difference (P = .96). Radiographic inspection showed no change in bone plug position, osteolysis, adverse effect, or complication caused by the bioabsorbable material. Some evidence of tunnel widening was seen in both groups. Conclusions: Use of a poly-L-lactic bioabsorbable interference screw call provide clinical results equal to that of a metal interference screw for fixation of a central third bone-patellar tendon-bone graft in ACL reconstruction.