Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw
ACL Reconstruction - Bioabsorbable Screws- 2 Year Follow-up
1 other identifier
observational
67
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 15, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJanuary 14, 2025
January 1, 2025
1.5 years
February 15, 2010
January 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Screw integrity
2-4 yrs
Tunnel enlargement
2-4 years
Study Arms (2)
Calaxo
Received Calaxo screw
Milagro
Received a Milagro screw
Eligibility Criteria
Patients 2-4 years post ACL reconstruction performed by Dr. Kurt Spindler, under age 35, injured in sport, unilateral primary ACL.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt University Medical Centerlead
- Smith & Nephew, Inc.collaborator
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8774, United States
Related Publications (1)
Cox CL, Spindler KP, Leonard JP, Morris BJ, Dunn WR, Reinke EK. Do newer-generation bioabsorbable screws become incorporated into bone at two years after ACL reconstruction with patellar tendon graft?: A cohort study. J Bone Joint Surg Am. 2014 Feb 5;96(3):244-50. doi: 10.2106/JBJS.L.01652.
PMID: 24500587RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kurt P Spindler, M.D.
Vanderbilt University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 15, 2010
First Posted
February 17, 2010
Study Start
December 1, 2009
Primary Completion
June 1, 2011
Study Completion
April 1, 2012
Last Updated
January 14, 2025
Record last verified: 2025-01