ACL TearNCT02450292
Retrospective CT Imaging of BioComposite Interference Screw With BTB
An observational study of ACL Tear, run by State University of New York at Buffalo.
Trial summary
The purpose of this study is to examine the long-term appearance and resorption rate of biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ACL Tear
- What is being tested?
- Bioabsorbable screw fixation
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jul 2016
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults aged 18+ who had an anterior cruciate ligament (ACL) reconstruction about 5 years ago performed by one of the study investigators.
Who may be able to join
- Ages 18-50
- Patients who underwent primary ACL reconstruction performed by one of the study investigators at least 5 years ago
- Isolated ACL tear
- Type of graft used was bone-patellar tendon-bone autograft
- Type of screw used to attach graft to the tibia and/or femur was a BioComposite interference screws (Arthrex, Inc.)
- No degenerative joint disease on preoperative X-rays (> 50% joint space loss, presence of osteophytes)
Who cannot join
- Revision ACL reconstructions
- Types of grafts other than bone-patellar tendon-bone autograft were used
- ACL tear with concomitant pathology
- Degenerative joint disease on preoperative X-ray (> 50% joint space loss, presence of osteophytes)
- Metal or other types of bioabsorbable screws other than BioComposite interference screws (Arthrex, Inc.) were used
- ACL reconstruction performed less than 5 years ago
Show all 9Show fewer
- Pregnancy
- Greater than Grade 2 laxity of other ligaments
- No additional fixation
About this study
Official title: Retrospective CT Imaging of BioComposite Interference Screw in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Graft
The purpose of this study is to examine the long-term appearance and resorption rate of biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).
- Conditions
- ACL Tear
- Being tested
- Bioabsorbable screw fixation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioabsorbable screw fixationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Screw resorption
Evaluated on X-ray and CT
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL TearStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Fineberg, State University of New York at Buffalo
- Investigators
- Marc Fineberg, MD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450292
- Sponsor's protocol ID
- 758594-1
- Status last verified
- Nov 2022
- First submitted
- 18 May 2015
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective CT Imaging of BioComposite Interference Screw in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Graft
- ClinicalTrials.gov ID
- NCT02450292
- Acronym / sponsor ID
- 758594-1
- Conditions
- ACL Tear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 May 2015 (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 this study is to examine the long-term appearance and resorption rate of biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults aged 18+ who had an anterior cruciate ligament (ACL) reconstruction about 5 years ago performed by one of the study investigators.
Key inclusion criteria (6 listed)
- Ages 18-50
- Patients who underwent primary ACL reconstruction performed by one of the study investigators at least 5 years ago
- Isolated ACL tear
- Type of graft used was bone-patellar tendon-bone autograft
- Type of screw used to attach graft to the tibia and/or femur was a BioComposite interference screws (Arthrex, Inc.)
Key exclusion criteria (9 listed)
- Revision ACL reconstructions
- Types of grafts other than bone-patellar tendon-bone autograft were used
- ACL tear with concomitant pathology
- Degenerative joint disease on preoperative X-ray (> 50% joint space loss, presence of osteophytes)
- Metal or other types of bioabsorbable screws other than BioComposite interference screws (Arthrex, Inc.) were used
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 |
|---|---|---|
| Bioabsorbable screw fixation | Procedure or surgery | – |
Primary outcome
Screw resorption
Time frame: 5 years
Evaluated on X-ray and CT
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 16 Nov 2022.
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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.
Marc Fineberg, MD principal investigator
University at Buffalo
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Tear, run by State University of New York at Buffalo.
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 6 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 16 Nov 2022. 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 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?
Screw resorption (time frame: 5 years). 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 16 Nov 2022.