NCT00374491 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Athanasiou KA, Agrawal CM, Barber FA, Burkhart SS
Orthopaedic applications for PLA-PGA biodegradable polymers. Arthroscopy. 1998 Oct;14(7):726-37. Review.
Bach FD, Carlier RY, Elis JB, Mompoint DM, Feydy A, Judet O, Beaufils P, Vallée C
Anterior cruciate ligament reconstruction with bioabsorbable polyglycolic acid interference screws: MR imaging follow-up. Radiology. 2002 Nov;225(2):541-50.
Barber FA, Elrod BF, McGuire DA, Paulos LE
Bioscrew fixation of patellar tendon autografts. Biomaterials. 2000 Dec;21(24):2623-9.
Barber FA, Elrod BF, McGuire DA, Paulos LE
Preliminary results of an absorbable interference screw. Arthroscopy. 1995 Oct;11(5):537-48.
Fankhauser F, Passler JM, Schippinger G, Boldin C, Scarpatetti M
Tendon-to-bone healing of a quadrupled hamstring tendon graft fixed with biodegradable screws in an immature athlete: a radiologic, arthroscopic, histologic, and electromicroscopic investigation. Arthroscopy. 2004 Nov;20(9):992-7.
Fink C, Benedetto KP, Hackl W, Hoser C, Freund MC, Rieger M
Bioabsorbable polyglyconate interference screw fixation in anterior cruciate ligament reconstruction: a prospective computed tomography-controlled study. Arthroscopy. 2000 Jul-Aug;16(5):491-8.
McGuire DA, Barber FA, Elrod BF, Paulos LE
Bioabsorbable interference screws for graft fixation in anterior cruciate ligament reconstruction. Arthroscopy. 1999 Jul-Aug;15(5):463-73.
Schwach G, Vert M
In vitro and in vivo degradation of lactic acid-based interference screws used in cruciate ligament reconstruction. Int J Biol Macromol. 1999 Jun-Jul;25(1-3):283-91.

The Long-term Degradation Outcome of Bilok Biodegradable Interference Fixation Screws Used for Bone-Patellar Tendon-Bone ACL Reconstruction

Details for clinical trial NCT00374491

Clinical trial NCT00374491 - References