NCT00374491

Brief Summary

The purpose of the study is to evaluate the long term outcome of a poly L-lactic acid / β-tricalcium phosphate (BILOK) biodegradable interference fixation screw used for arthroscopic bone-patellar tendon-bone ACL reconstruction,to determine if these BILOK screws completely biodegrade as expected three years after implantation, and to determine whether there is bone ingrowth into the defect remaining after resorption of the BILOK screw.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

First QC Date

September 7, 2006

Last Update Submit

January 4, 2016

Conditions

Anterior Cruciate Ligament

Keywords

ACLBone ScrewKnee

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Prior patellar tendon autograft ACL reconstruction that used poly L-lactic acid (BILOK) interference fixation screws.
  • Minimum follow-up of 3 years after the index surgery.
  • Subject must be able to understand the verbiage of the consent form.
  • The subject must be willing to undergo a physical examination of the previously operated knee.
  • The subject must be willing to undergo a radiographic examination of the previously operated knee.
  • The subject must be willing to undergo a CT scan examination of the previously operated knee.
  • The subject signs the IRB-approved informed consent form.
  • The subject is willing and able to complete required follow-up.

You may not qualify if:

  • Subsequent ACL surgery or bone procedures in the area of the ACL graft attachments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Barber FA, Elrod BF, McGuire DA, Paulos LE. Preliminary results of an absorbable interference screw. Arthroscopy. 1995 Oct;11(5):537-48. doi: 10.1016/0749-8063(95)90129-9.

    PMID: 8534294BACKGROUND

  • Athanasiou KA, Agrawal CM, Barber FA, Burkhart SS. Orthopaedic applications for PLA-PGA biodegradable polymers. Arthroscopy. 1998 Oct;14(7):726-37. doi: 10.1016/s0749-8063(98)70099-4.

    PMID: 9788368BACKGROUND

  • 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. doi: 10.1053/ar.1999.v15.015046001.

    PMID: 10424549BACKGROUND

  • Barber FA, Elrod BF, McGuire DA, Paulos LE. Bioscrew fixation of patellar tendon autografts. Biomaterials. 2000 Dec;21(24):2623-9. doi: 10.1016/s0142-9612(00)00130-7.

    PMID: 11071612BACKGROUND

  • 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. doi: 10.1016/j.arthro.2004.08.007.

    PMID: 15525934BACKGROUND

  • 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. doi: 10.1016/s0141-8130(99)00043-4.

    PMID: 10416676BACKGROUND

  • Bach FD, Carlier RY, Elis JB, Mompoint DM, Feydy A, Judet O, Beaufils P, Vallee C. Anterior cruciate ligament reconstruction with bioabsorbable polyglycolic acid interference screws: MR imaging follow-up. Radiology. 2002 Nov;225(2):541-50. doi: 10.1148/radiol.2252010357.

    PMID: 12409593BACKGROUND

  • 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. doi: 10.1053/jars.2000.4633.

    PMID: 10882444BACKGROUND

Study Officials

  • F. Alan Barber, MD

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 11, 2006

Study Start

September 1, 2006

Last Updated

January 5, 2016

Record last verified: 2016-01