Kaeding Christopher, Farr Jack, Kavanaugh Tim, Pedroza Angela
Department of Orthopaedics, The Ohio State University, Columbus, Ohio, USA.
Arthroscopy. 2005 Feb;21(2):147-51. doi: 10.1016/j.arthro.2004.09.012.
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.
Multicentered prospective randomized study.
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 at 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.
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.
Use of a poly-L-lactic bioabsorbable interference screw can 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.
Level II, therapeutic.
比较幻影生物可吸收聚合物干涉螺钉（迪普伊公司，印第安纳州华沙市）与钛金属干涉螺钉在中央三分之一骨-髌腱-骨自体移植前交叉韧带（ACL）重建中用于固定股骨和胫骨骨块时的效果。
多中心前瞻性随机研究。
两名外科医生在不同地点进行初次ACL重建手术。术前，患者被随机分组。一组接受钛制空心干涉螺钉。第二组接受聚-L-乳酸空心生物可吸收幻影螺钉。数据包括对活动水平的主观评估和国际膝关节文献委员会评分。使用KT-1000关节测量仪（MedMetric公司，加利福尼亚州圣地亚哥市）、活动范围、有无积液以及术中或术后并发症等进行客观测量。在1年和2年时进行测量。在初次手术日期至少2年后进行影像学评估，并由2名独立的骨科医生解读。
在1年随访时（N = 97），幻影螺钉组（6例）在中度活动时报告的疼痛比钛螺钉组（0例）更多（P = 0.03）。在活动范围（P = 0.45）、活动水平（P = 0.83）、活动时肿胀（P = 0.95）、部分（P = 0.13）或完全（P = 0.31）松弛、膝关节积液（P = 0.33）或KT-1000两侧差值（P = 0.53）方面未发现统计学差异。在2年随访时（N = 65），与钛干涉螺钉组（7例）相比，幻影干涉螺钉组更多受试者（18例）报告活动水平处于剧烈类别（P = 0.02）。在疼痛（P = 0.97）、积液（P = 0.17）、部分（P = 0.28）或完全（P = 0.27）松弛、活动时肿胀（P = 0.21）、活动范围（P = 0.64）或KT-1000两侧差值（P = 0.96）方面未报告有差异。影像学检查显示骨栓位置、骨质溶解、生物可吸收材料引起的不良反应或并发症均无变化。两组均可见一些隧道增宽的迹象。
在ACL重建中，使用聚-L-乳酸生物可吸收干涉螺钉固定中央三分之一骨-髌腱-骨移植物可提供与金属干涉螺钉相当的临床效果。
二级，治疗性。
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