- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374491
The Long-term Degradation Outcome of Bilok Screws Used for ACL Reconstruction
January 4, 2016 updated by: ArthroCare Corporation
The Long-term Degradation Outcome of Bilok Biodegradable Interference Fixation Screws Used for Bone-Patellar Tendon-Bone ACL Reconstruction
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.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
BILOK screws have been used for ACL interference fixation in the US since the late 1990s.
As yet, there are no long-term studies to demonstrate the eventual biologic outcome of these devices.
Animal studies indicate that the material used in BILOK implants completely degrades after 3 years, but these reports do not indicate what takes their place.
Reports of other screw materials indicate that pure PLLA screws remain intact and can be removed whole at revision surgery in the first few months to years after implantation.
Recently a report of a biopsy at 2 years after surgery indicated that whole fragments of a PLLA screw were observed.
Schwach and Vert suggested that a PDLLA screw (combination of dextro and levo stereoisomers) completely degrade and is replaced by bone 3 years after surgery in sheep but no information is available for the human.
In addition to being limited and anecdotal, most studies evaluating the degradation of biodegradable screws used in humans are conducted using plain radiographs and MRI to evaluate the status of the biodegradable screws.
A report by Bach et al evaluated the MRI appearance of a biodegradable interference screw composed of a different polymer (polyglycolic acid 67% and trimethylene carbonate 33%) in eight patients at 2 years.
It showed the reabsorption of the screw but suggested that MRI is not the most effective method for determining the bone ingrowth status in the area of the resorbed screws.
CT scanning is a better methodology than MRI for this application and was recently used to study the disappearance of a pure PLLA screw at least 7 years after implantation.
The purpose of this study is to evaluate the long-term resorption status of a Bilok screw and determine, using CT scan, what material replaces the screw.
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subsequent ACL surgery or bone procedures in the area of the ACL graft attachments.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: F. Alan Barber, MD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
September 7, 2006
First Submitted That Met QC Criteria
September 7, 2006
First Posted (Estimate)
September 11, 2006
Study Record Updates
Last Update Posted (Estimate)
January 5, 2016
Last Update Submitted That Met QC Criteria
January 4, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- A0506JM
- 20061028
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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