Joint Infection Following ACL Reconstruction

Joint Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948281
• Other study ID #: M2017332
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 findings with their possible factors.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 31, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infection
• Joint Infection

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Peking university third hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year after operation/infection
Primary	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.	1 year after operation/infection
Primary	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.	1 year after operation/infection