Poly L-Lactide Co-Glycolide/β-Tricalcium Phosphate Interference Screw Fixation for Bone-Patellar Tendon Bone Anterior Cruciate Ligament Reconstruction

Abstract

The objective of this study was to prospectively evaluate the clinical effectiveness and radiographic response of a poly (l-lactide co-glycolide)/β-tricalcium phosphate (PlLA/PGA/β-TCP) interference screw used in bone-patellar tendon-bone (BPTB) anterior cruciate ligament (ACL) reconstruction. A prospective, consecutive series of 104 patellar tendon bone-tendon-bone ACL reconstructions fixed with PLLA/PGA/β-TCP biocomposite screws were studied. After receiving the approval from the Institutional Review Board, the following data were collected preoperatively from all patients: physical examination, Lysholm score, Cincinnati, and International Knee Documentation Committee (IKDC) activity scores, and standard knee radiographs. In addition to these, follow-up assessments included Lachman and pivot-shift tests, Tegner scores, and KT side-to-side differences. Surgical failure was defined by a 2+ Lachman test, positive pivot-shift test, side-to-side KT difference of greater than 5 mm or subsequent ACL revision surgery. Approximately 95% of patients (99 of 104) with an average follow-up of 36 months (range, 24 to 68) are reported. The average age was 30 years (range, 13 to 57 years). Postoperatively, four patients demonstrated +1 Lachman score and one patient demonstrated a +2 Lachman score. Postoperative pivot-shift tests were a trace positive in one patients and +1 in two patients. The average KT side-to-side difference was 0.65 mm. All, but five patients, demonstrated KT side-to-side measurements of 3 mm or less and those five demonstrated measurements of 5 mm or less. No revision reconstructions were performed. Significant improvements in Cincinnati score (41 to 85 postoperative) and Lysholm score (46 to 90) were observed. The average postoperative Tegner score was 7. IKDC activity score increased from 2.3 to 3.1. Approximately 4% of patients (4 of 99) met the criteria for failure. A PLLA/PGA/β-TCP biocomposite interference fixation screw provides good graft fixation, with good radiographic incorporation, without adverse events.

The level of evidence of the study is IV.

Keywords

anterior cruciate ligament - PLLA/PGA screw - interference screw - biocomposite

• References

• 1 Konan S, Haddad FS. The unpredictable material properties of bioabsorbable PLC interference screws and their adverse effects in ACL reconstruction surgery. Knee Surg Sports Traumatol Arthrosc 2009; 17 (3) 293-297
• 2 Konan S, Haddad FS. A clinical review of bioabsorbable interference screws and their adverse effects in anterior cruciate ligament reconstruction surgery. Knee 2009; 16 (1) 6-13
• 3 Barber FA, Boothby MH. Bilok interference screws for anterior cruciate ligament reconstruction: clinical and radiographic outcomes. Arthroscopy 2007; 23 (5) 476-481
• 4 Barber FA, Dockery WD, Hrnack SA. Long-term degradation of a poly-lactide co-glycolide/β-tricalcium phosphate biocomposite interference screw. Arthroscopy 2011; 27 (5) 637-643
• 5 Barber FA. Poly-d, l-lactide interference screws for anterior cruciate ligament reconstruction. Arthroscopy 2005; 21 (7) 804-808
• 6 Barber FA, Elrod BF, McGuire DA, Paulos LE. Preliminary results of an absorbable interference screw. Arthroscopy 1995; 11 (5) 537-548
• 7 McGuire DA, Barber FA, Elrod BF, Paulos LE. Bioabsorbable interference screws for graft fixation in anterior cruciate ligament reconstruction. Arthroscopy 1999; 15 (5) 463-473
• 8 Raffo CS, Pizzarello P, Richmond JC, Pathare N. A reproducible landmark for the tibial tunnel origin in anterior cruciate ligament reconstruction: avoiding a vertical graft in the coronal plane. Arthroscopy 2008; 24 (7) 843-845
• 9 Shaieb MD, Kan DM, Chang SK, Marumoto JM, Richardson AB. A prospective randomized comparison of patellar tendon versus semitendinosus and gracilis tendon autografts for anterior cruciate ligament reconstruction. Am J Sports Med 2002; 30 (2) 214-220
• 10 Sajovic M, Vengust V, Komadina R, Tavcar R, Skaza K. A prospective, randomized comparison of semitendinosus and gracilis tendon versus patellar tendon autografts for anterior cruciate ligament reconstruction: five-year follow-up. Am J Sports Med 2006; 34 (12) 1933-1940
• 11 Niki Y, Matsumoto H, Hakozaki A, Kanagawa H, Toyama Y, Suda Y. Anatomic double-bundle anterior cruciate ligament reconstruction using bone-patellar tendon-bone and gracilis tendon graft: a comparative study with 2-year follow-up results of semitendinosus tendon grafts alone or semitendinosus-gracilis tendon grafts. Arthroscopy 2011; 27 (9) 1242-1251
• 12 Frosch KH, Sawallich T, Schütze G , et al. Magnetic resonance imaging analysis of the bioabsorbable Milagro interference screw for graft fixation in anterior cruciate ligament reconstruction. Strateg Trauma Limb Reconstr 2009; 4 (2) 73-79
• 13 Agrawal CM, Athanasiou KA. Technique to control pH in vicinity of biodegrading PLA-PGA implants. J Biomed Mater Res 1997; 38 (2) 105-114
• 14 Barber FA, Dockery WD. Long-term absorption of beta-tricalcium phosphate poly-L-lactic acid interference screws. Arthroscopy 2008; 24 (4) 441-447
• 15 Barber FA, Aziz-Jacobo J, Oro FB. Anterior cruciate ligament reconstruction using patellar tendon allograft: an age-dependent outcome evaluation. Arthroscopy 2010; 26 (4) 488-493
• 16 Tecklenburg K, Burkart P, Hoser C, Rieger M, Fink C. Prospective evaluation of patellar tendon graft fixation in anterior cruciate ligament reconstruction comparing composite bioabsorbable and allograft interference screws. Arthroscopy 2006; 22 (9) 993-999
• 17 Barber FA, Spruill B, Sheluga M. The effect of outlet fixation on tunnel widening. Arthroscopy 2003; 19 (5) 485-492
• 18 Weiler A, Hoffmann RF, Bail HJ, Rehm O, Südkamp NP. Tendon healing in a bone tunnel. Part II: Histologic analysis after biodegradable interference fit fixation in a model of anterior cruciate ligament reconstruction in sheep. Arthroscopy 2002; 18 (2) 124-135
• 19 Barber FA. Flipped patellar tendon autograft anterior cruciate ligament reconstruction. Arthroscopy 2000; 16 (5) 483-490
• 20 Fauno P, Kaalund S. Tunnel widening after hamstring anterior cruciate ligament reconstruction is influenced by the type of graft fixation used: a prospective randomized study. Arthroscopy 2005; 21 (11) 1337-1341
• 21 Rodeo SA, Arnoczky SP, Torzilli PA, Hidaka C, Warren RF. Tendon-healing in a bone tunnel. A biomechanical and histological study in the dog. J Bone Joint Surg Am 1993; 75 (12) 1795-1803
• 22 Brand Jr JC, Nyland J, Caborn DN, Johnson DL. Soft-tissue interference fixation: bioabsorbable screw versus metal screw. Arthroscopy 2005; 21 (8) 911-916
• 23 Brand Jr JC, Pienkowski D, Steenlage E, Hamilton D, Johnson DL, Caborn DN. Interference screw fixation strength of a quadrupled hamstring tendon graft is directly related to bone mineral density and insertion torque. Am J Sports Med 2000; 28 (5) 705-710
• 24 Hantes ME, Mastrokalos DS, Yu J, Paessler HH. The effect of early motion on tibial tunnel widening after anterior cruciate ligament replacement using hamstring tendon grafts. Arthroscopy 2004; 20 (6) 572-580
• 25 Cox CL, Homlar KC, Carey JL, Spindler KP. CALAXO osteoconductive interference screw: the value of postmarket surveillance. J Surg Orthop Adv 2010; 19 (2) 121-124