Joint Infection Following ACL Reconstruction

NCT04948281 | Completed DMC

• 1 other identifier: M2017332
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Joint Infection

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Infection Group

A group of joint infection patients after arthroscopic ACL reconstruction surgery , diagnose was made according to American CDC criteria of joint infection

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.

Other: no intervention

Interventions

no intervention OTHER

no intervention

Control Group; Infection Group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Concomitant ligament injury which need surgical repair;
• Delayed onset of postoperative joint infection (\>3 months after surgery).

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

Location

Study Officials

• yingfang ao, M.D.

  Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 1, 2021
• Study Start: January 1, 2019
• Primary Completion: January 1, 2019
• Study Completion: December 31, 2020
• Last Updated: July 12, 2021

Record last verified: 2021-06

Locations

CN (1)