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Completed

NCT Number: NCT04948281

Joint Infection Following ACL Reconstruction

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.

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Key information

Conditions

Joint Infection

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

The Effects of Joint Infection Following Arthroscopic Single-bundle ACL Reconstruction With Autologous Hamstring: a Retrospective Matched Cohort Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 1, 2021
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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