- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01069588
Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw
February 19, 2024 updated by: Kurt P. Spindler, Vanderbilt University Medical Center
ACL Reconstruction - Bioabsorbable Screws- 2 Year Follow-up
To evaluate the knee functionality, screw integrity, graft integrity, cartilage effect, and bony ingrowth in patients treated with the CALAXO screw and MILAGRO screw two years after ACL reconstruction.
Study Overview
Status
Completed
Conditions
Detailed Description
This study will combine the use of survey response, MRI, and x-rays of the knees in Dr. Spindler's ACL reconstructed patients in order to examine long term healing of two types of bioabsorbable screw.
We will use a 2-4 yr time point to look at patient reported symptoms of pain and swelling from the surveys and use the x-rays and MRIs to look at absorption of the screw, healing of the graft, and body reactions to the screw.
Study Type
Observational
Enrollment (Actual)
67
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37232-8774
- Vanderbilt University Medical Center
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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
12 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients 2-4 years post ACL reconstruction performed by Dr. Kurt Spindler, under age 35, injured in sport, unilateral primary ACL.
Description
Inclusion Criteria:
- Age range: 12-35 years of age at the time of follow-up.
- Gender: Both.
- Minorities: All.
- Involved in sports at the time of injury.
- Participants must be at least two years past the date of ACL reconstruction surgery and not more than four years past the date of surgery
- Bioabsorbable Screws used during ACL reconstruction surgery
Exclusion Criteria:
- Age: <12 or >35 years of age
- Non-active or unable to participate for health reasons
- Simultaneous bilateral ACL reconstruction surgeries.
If any of the following conditions exist in the ipsilateral knee:
- Revision ACL reconstruction
- Complex knee injury
If any of the following conditions exist in the contralateral knee:
- ACL deficient
- Prior ACL reconstruction
- Prior surgery of any type
- Insufficient initial documentation
- Cannot be contacted by phone
- Neither Calaxo nor Milagro screw used at the time of ACL reconstruction
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
Cohorts and Interventions
Group / Cohort |
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Calaxo
Received Calaxo screw
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Milagro
Received a Milagro screw
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Screw integrity
Time Frame: 2-4 yrs
|
2-4 yrs
|
Tunnel enlargement
Time Frame: 2-4 years
|
2-4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kurt P Spindler, M.D., Vanderbilt University Medical Center
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.
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
December 1, 2009
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
February 15, 2010
First Submitted That Met QC Criteria
February 16, 2010
First Posted (Estimated)
February 17, 2010
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 19, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 090805
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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