Rupture of Anterior Cruciate LigamentNCT01069588
Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw
An observational study of Rupture of Anterior Cruciate Ligament, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Apr 2012
- 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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients 2-4 years post ACL reconstruction performed by Dr. Kurt Spindler, under age 35, injured in sport, unilateral primary ACL.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8774
About this study
Official title: 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.
Read the 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.
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- bioabsorbable screw, acl reconstruction
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Calaxo | Received Calaxo screw | |
| Milagro | Received a Milagro screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screw integrity
Measured: 2-4 yrs
Tunnel enlargement
Measured: 2-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rupture of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Principal investigator, Kurt P. Spindler, Vanderbilt University Medical Center
- Investigators
- Kurt P Spindler, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069588
- Sponsor's protocol ID
- 090805
- Status last verified
- Jan 2025
- First submitted
- 15 Feb 2010
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24500587
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACL Reconstruction - Bioabsorbable Screws- 2 Year Follow-up
- ClinicalTrials.gov ID
- NCT01069588
- Acronym / sponsor ID
- 090805
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- bioabsorbable screw, acl reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 17 Feb 2010 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calaxo | – | –Received Calaxo screw |
| Milagro | – | –Received a Milagro screw |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients 2-4 years post ACL reconstruction performed by Dr. Kurt Spindler, under age 35, injured in sport, unilateral primary ACL.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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:
- If any of the following conditions exist in the contralateral knee:
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
Screw integrity
Time frame: 2-4 yrs
Tunnel enlargement
Time frame: 2-4 years
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 14 Jan 2025.
- Results publication: PubMed 24500587Cox 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.
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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.
Kurt P Spindler, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rupture of Anterior Cruciate Ligament, run by Vanderbilt University Medical Center at 1 site in United States.
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 13 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 14 Jan 2025. 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 United States. 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?
Screw integrity (time frame: 2-4 yrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01069588, which also lists 1 linked publication.
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 14 Jan 2025.