Anterior Cruciate LigamentNCT00374491
The Long-term Degradation Outcome of Bilok Screws Used for ACL Reconstruction
An observational study of Anterior Cruciate Ligament, run by ArthroCare Corporation.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Subsequent ACL surgery or bone procedures in the area of the ACL graft attachments.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament
- Keywords
- ACL, Bone Screw, Knee
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate LigamentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ArthroCare Corporation
- Sponsor type
- University, hospital or other
- Investigators
- F. Alan Barber, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374491
- Sponsor's protocol ID
- A0506JM
- Other IDs
- 20061028
- Status last verified
- Jan 2016
- First submitted
- 7 Sep 2006
- Last updated
- 5 Jan 2016
- Results posted
- No
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.
PubMed 8534294Athanasiou 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.
PubMed 9788368McGuire 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.
PubMed 10424549Barber 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.
PubMed 11071612Fankhauser 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.
PubMed 15525934Schwach 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.
PubMed 10416676Bach 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.
PubMed 12409593Fink 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.
PubMed 10882444
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Degradation Outcome of Bilok Biodegradable Interference Fixation Screws Used for Bone-Patellar Tendon-Bone ACL Reconstruction
- ClinicalTrials.gov ID
- NCT00374491
- Acronym / sponsor ID
- A0506JM
- Conditions
- Anterior Cruciate Ligament
- Keywords
- ACL, Bone Screw, Knee
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ArthroCare CorporationUniversity, hospital or other
- Study start
- Sep 2006
- First posted
- 11 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- Subsequent ACL surgery or bone procedures in the area of the ACL graft attachments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Background: PubMed 8534294Barber 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.
- Background: PubMed 9788368Athanasiou 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.
- Background: PubMed 10424549McGuire 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.
- Background: PubMed 11071612Barber 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.
- Background: PubMed 15525934Fankhauser 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.
- Background: PubMed 10416676Schwach 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.
- Background: PubMed 12409593Bach 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.
- Background: PubMed 10882444Fink 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F. Alan Barber, MD principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament, run by ArthroCare Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00374491, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.