Joint InfectionNCT04948281
Joint Infection Following ACL Reconstruction
An observational study of Joint Infection, run by Peking University Third Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Joint Infection
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2020
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population were from 20549 arthroscopic ACL reconstruction surgeries in our institute between January 2002 to December 2017.
Who may be able to join
- 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
Who cannot join
- Concomitant ligament injury which need surgical repair;
- Delayed onset of postoperative joint infection (>3 months after surgery).
Trial locations and contacts
1 site in 1 country.
China1 site
Peking university third hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: 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.
Read the 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.
- Conditions
- Joint Infection
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Infection Group | A group of joint infection patients after arthroscopic ACL reconstruction surgery , diagnose was made according to American CDC criteria of joint infection Receives: Other: 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. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tunnel enlargement
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)
Measured: 1 year after operation/infection
Graft signal intensity
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.
Measured: 1 year after operation/infection
Cartilage morphology
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.
Measured: 1 year after operation/infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Jan 2019
- Primary completion1 Jan 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint InfectionStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yingfang ao, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948281
- Sponsor's protocol ID
- M2017332
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Joint Infection Following Arthroscopic Single-bundle ACL Reconstruction With Autologous Hamstring: a Retrospective Matched Cohort Study
- ClinicalTrials.gov ID
- NCT04948281
- Acronym / sponsor ID
- M2017332
- Conditions
- Joint Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Jul 2021 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infection Group | – | Other: no interventionA group of joint infection patients after arthroscopic ACL reconstruction surgery , diagnose was made according to American CDC criteria of joint infection |
| Control Group | – | Other: no interventionA group of patients which were matched to infections group retrospectively one-to-three who did not sustain any kind of infection after ACL reconstruction. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population were from 20549 arthroscopic ACL reconstruction surgeries in our institute between January 2002 to December 2017.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Concomitant ligament injury which need surgical repair;
- Delayed onset of postoperative joint infection (>3 months after surgery).
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 |
|---|---|---|
| no interventionno intervention | Other | Control Group, Infection Group |
Primary outcome
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)
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.
Cartilage morphology
Time frame: 1 year after operation/infection
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.
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 12 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
yingfang ao, M.D. study chair
Peking University Third Hospital
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 Joint Infection, run by Peking University Third Hospital at 1 site in China.
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 3 inclusion and 2 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 12 Jul 2021. 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 China. 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?
Tunnel enlargement (time frame: 1 year after operation/infection). The study lists 3 primary outcomes in all. 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 12 Jul 2021.