- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04948281
Joint Infection Following ACL Reconstruction
July 8, 2021 updated by: Peking University Third Hospital
The Effects of Joint Infection Following Arthroscopic Single-bundle ACL Reconstruction With Autologous Hamstring: a Retrospective Matched Cohort Study
This study was conducted to analyze the effect of joint infection on the bone tunnel, graft and articular cartilage following arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with autologous hamstring, to summarize the features of MR findings after joint infection, and to correlate these findings with their possible factors.
Study Overview
Detailed Description
A retrospective matched cohort study was performed in 26 patients who underwent arthroscopic single-bundle ACL reconstruction with hamstring graft and developed postoperative joint infection in our institute from January 2002 to December 2017.
They were matched 1:3 to patients who did not sustain joint infection after ACL reconstruction.
MR scan was collected at the time of follow-up.
Bone tunnel enlargement at tunnel aperture, midsection and exit of tibial and femoral tunnel was carefully assessed.
Graft signal-to-noise quotient (SNQ) on MRI was calculated to evaluate graft maturity.
Cartilage morphology was graded using Whole Organ Magnetic Resonance Imaging Score.
A generalized linear mixed model was applied to analyze the effect of joint infection on the bone tunnel, graft and articular cartilage.
Study Type
Observational
Enrollment (Actual)
104
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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Beijing
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Beijing, Beijing, China, 100191
- Peking University Third Hospital
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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
16 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The study population were from 20549 arthroscopic ACL reconstruction surgeries in our institute between January 2002 to December 2017.
Description
Inclusion Criteria:
- Age between 16 to 50 years;
- Underwent single-bundle ACL reconstruction with autologous hamstring;
- Had valid follow-up magnetic resonance imaging (MRI) at least 1 year after surgery
Exclusion Criteria:
- Concomitant ligament injury which need surgical repair;
- Delayed onset of postoperative joint infection (>3 months after surgery).
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 |
Intervention / Treatment |
|---|---|
|
Infection Group
A group of joint infection patients after arthroscopic ACL reconstruction surgery , diagnose was made according to American CDC criteria of joint infection
|
no intervention
|
|
Control Group
A group of patients which were matched to infections group retrospectively one-to-three who did not sustain any kind of infection after ACL reconstruction.
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no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tunnel enlargement
Time Frame: 1 year after operation/infection
|
A 3.0T MRI unit (General Electric Healthcare) with an 8-channel coil was used for measurement.
Anteroposterior and lateromedial diameter at tunnel aperture, midsection and exit of tibial and femoral tunnel (demonstrated as TTa, TTm, TTe, FTa, FTm, FTe) was measured on T1-weighted images (in millimeters)
|
1 year after operation/infection
|
|
Graft signal intensity
Time Frame: 1 year after operation/infection
|
Proton Density weighted fat suppressed turbo-spin echo (PD-TSE-FS) sequence was taken to calculate the SNQof the graft.
Graft signal intensity was measured at proximal, middle and distal end of the graft.
|
1 year after operation/infection
|
|
Cartilage morphology
Time Frame: 1 year after operation/infection
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The cartilage morphology at surgery was assessed using Outerbridge classification for chondral lesion and recorded in operation note.
cartilage morphology was assessed according to the Whole-organ magnetic scoring system (WORMS) of the knee on sagittal and axial T2-weighted FSE images.
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1 year after operation/infection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: yingfang ao, M.D., Peking University Third Hospital
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 (Actual)
January 1, 2019
Primary Completion (Actual)
January 1, 2019
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
June 27, 2021
First Submitted That Met QC Criteria
June 27, 2021
First Posted (Actual)
July 1, 2021
Study Record Updates
Last Update Posted (Actual)
July 12, 2021
Last Update Submitted That Met QC Criteria
July 8, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2017332
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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