ACLNCT01727739
Tibial Tunnel Widening in Anterior Cruciate Ligament (ACL) Reconstruction-Comparing Two Bioscrews
A study testing Linvatec PLLA+TCP and Linvatec PLLA in people with ACL, run by Panam Clinic at 1 site in Canada.
Trial summary
Widening of the single tibial tunnel following ACL surgery with quadrupled hamstrings autograft may contribute to failure of the graft and/or present technical challenges secondary to bone loss in a revision setting (Getelman, 1999). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- ACL
- What is being tested?
- Linvatec PLLA+TCP and Linvatec PLLA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Dec 2018
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must have a unilateral ACL rupture
- Patients must be between 18 and 45 years old
Who cannot join
- Concomitant medial collateral, lateral collateral, or posterior collateral ligament tears
- Severe chondromalacia or severe meniscal tear
- Previous history of ipsilateral knee joint pathology, surgery, or trauma to that knee
- Unwillingness to be followed for 12 months post-operatively
- History of arthritis (osteoarthritis or rheumatoid)
- Pregnancy
Show all 9Show fewer
- Psychiatric illness that precludes informed consent
- Unable to speak or read English/French
- Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tibial Tunnel Widening in ACL Reconstruction-Comparing Two Bioscrews: A Prospective Randomized Clinical Trial
Widening of the single tibial tunnel following ACL surgery with quadrupled hamstrings autograft may contribute to failure of the graft and/or present technical challenges secondary to bone loss in a revision setting (Getelman, 1999). As such, efforts should be made to minimize the incidence and magnitude of tibial tunnel widening without sacrificing the biomechanical properties of the graft construct. The purpose of this investigation is to examine the tibial tunnel widening relationship between bioabsorbable interference screws composed of poly-L-lactic acid (PLLA) alone and composite bioabsorbable interference screws composed of poly-L-lactic acid embedded with beta tricalcium phosphate (PLLA+TCP) utilized as tibial fixation devices.
Specifically the study has the following objectives: 1) To quantify the extent of tibial tunnel enlargement at 3-, 6- and 12-months post ACL reconstruction with autogenous quadrupled hamstring graft; 2) To determine if the incorporation of beta tricalcium phosphate to the bioabsorbable interference screw alters the observed magnitude of tunnel widening; 3) To hypothesize mechanisms for any observed differences between tibial fixation devices; and 4) To correlate tibial tunnel widening with clinical outcome status. It is hypothesized that the PLLA+TCP bioabsorbable interference screw will not be associated with a reduction in tibial tunnel widening around the implant but rather between the implant and articular surface, compared to the PLLA alone screw. It is also hypothesized that there will be no effect of observed tunnel widening on clinical outcomes or graft failure rates.
- Conditions
- ACL
- Being tested
- Linvatec PLLA+TCP, Linvatec PLLA
- Keywords
- Tibial tunnel widening, Interference screws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linvatec PLLA+TCPDevice
Linvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction.
Linvatec PLLADevice
Linvatec PLLA tibial interference screw fixation will be used in ACL reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| PLLA bioscrew | Active comparator | poly-L-lactic acid bioscrew Receives: Device: Linvatec PLLA |
| PLLA+TCP bioscrew | Active comparator | poly-l-lactic acid with beta tricalcium phosphate bioscrew Receives: Device: Linvatec PLLA+TCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographs
At 3-, 6- and 12-months post-operatively, subjects will undergo radiographic examination of their affected knee (standardized AP and lateral views) for analysis of tibial tunnel parameters. Radiographic analysis will be conducted by a single orthopaedic surgeon/fellow/resident blinded to subject group and clinical examination results. Parameters to be recorded and analyzed according to a standardized method: tibial tunnel diameter (max/min).
We will also look for: Evidence of lysis in the tunnel and changes in morphological features of tunnel over time
Measured: 12 months post op
Secondary outcomes (1)
ACL Quality of Life Scores
Completed at 3-, 6- and 12-months post operatively for subjective outcome measure.
Measured: 12 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACLStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panam Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter MacDonald, Panam Clinic
- Investigators
- Peter B MacDonald, MD FRCS(C), Principal investigator, Pan Am Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727739
- Sponsor's protocol ID
- B2012:059
- Status last verified
- Mar 2019
- First submitted
- 7 Nov 2012
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tibial Tunnel Widening in ACL Reconstruction-Comparing Two Bioscrews: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01727739
- Acronym / sponsor ID
- B2012:059
- Conditions
- ACL
- Keywords
- Tibial tunnel widening, Interference screws
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Panam ClinicUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 16 Nov 2012 (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.
Widening of the single tibial tunnel following ACL surgery with quadrupled hamstrings autograft may contribute to failure of the graft and/or present technical challenges secondary to bone loss in a revision setting (Getelman, 1999). As such, efforts should be made to minimize the incidence and magnitude of tibial tunnel widening without sacrificing the biomechanical properties of the graft construct. The purpose of this investigation is to examine the tibial tunnel widening relationship between bioabsorbable interference screws composed of poly-L-lactic acid (PLLA) alone and composite bioabsorbable interference screws composed of poly-L-lactic acid embedded with beta tricalcium phosphate (PLLA+TCP) utilized as tibial fixation devices.
Specifically the study has the following objectives: 1) To quantify the extent of tibial tunnel enlargement at 3-, 6- and 12-months post ACL reconstruction with autogenous quadrupled hamstring graft; 2) To determine if the incorporation of beta tricalcium phosphate to the bioabsorbable interference screw alters the observed magnitude of tunnel widening; 3) To hypothesize mechanisms for any observed differences between tibial fixation devices; and 4) To correlate tibial tunnel widening with clinical outcome status. It is hypothesized that the PLLA+TCP bioabsorbable interference screw will not be associated with a reduction in tibial tunnel widening around the implant but rather between the implant and articular surface, compared to the PLLA alone screw. It is also hypothesized that there will be no effect of observed tunnel widening on clinical outcomes or graft failure rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLLA bioscrew | Active comparator | Device: Linvatec PLLApoly-L-lactic acid bioscrew |
| PLLA+TCP bioscrew | Active comparator | Device: Linvatec PLLA+TCPpoly-l-lactic acid with beta tricalcium phosphate bioscrew |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must have a unilateral ACL rupture
- Patients must be between 18 and 45 years old
Key exclusion criteria (9 listed)
- Concomitant medial collateral, lateral collateral, or posterior collateral ligament tears
- Severe chondromalacia or severe meniscal tear
- Previous history of ipsilateral knee joint pathology, surgery, or trauma to that knee
- Unwillingness to be followed for 12 months post-operatively
- History of arthritis (osteoarthritis or rheumatoid)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linvatec PLLA+TCPLinvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction. | Device | PLLA+TCP bioscrew |
| Linvatec PLLALinvatec PLLA tibial interference screw fixation will be used in ACL reconstruction. | Device | PLLA bioscrew |
Primary outcome
Radiographs
Time frame: 12 months post op
At 3-, 6- and 12-months post-operatively, subjects will undergo radiographic examination of their affected knee (standardized AP and lateral views) for analysis of tibial tunnel parameters. Radiographic analysis will be conducted by a single orthopaedic surgeon/fellow/resident blinded to subject group and clinical examination results. Parameters to be recorded and analyzed according to a standardized method: tibial tunnel diameter (max/min). We will also look for: Evidence of lysis in the tunnel and changes in morphological features of tunnel over time
1 secondary outcome
ACL Quality of Life Scores
Time frame: 12 months post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
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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.
Peter B MacDonald, MD FRCS(C) principal investigator
Pan Am Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linvatec PLLA+TCP and Linvatec PLLA in people with ACL, run by Panam Clinic at 1 site in Canada.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Radiographs (time frame: 12 months post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2019.