NCT07208968

Brief Summary

A single-center retrospective cohort study was conducted in the Department of Orthopedics of Fujian Medical University Affiliated First Hospital. This study reviewed 28 patients who received unicompartmental prosthetic joint infection (uPJI) treatment at this institution from 2017 to 2023. The personal information of the patients, including age, gender, affected side, age-adjusted Charles Syndrome Index (aCCI), inflammation markers, lesion range on magnetic resonance angiography (MARS-MRI), lesion range observed directly during surgery and surgical methods, were recorded in detail. The study evaluated the clinical decision-making of a standardized MARS-MRI-guided treatment protocol for uPJI by reviewing the clinical outcomes of uPJI patients in a single PJI center.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

6.1 years

First QC Date

September 21, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

Prosthetic joint infectionUnicompartmental knee arthroplastyAntibiotics and implant retentionOne-stage revisionUnicompartmental spacerMetal artefact reduction sequence magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

  • Infection control or not according to the MSIS criteria

    According to the Musculoskeletal Infection Society (MSIS) criteria, infection control was defined as no local inflammation, infection/aseptic revision, or uPJI-related death within 1 year of the initial surgery.

    preoperative and two-year follow-up

  • The Hospital for Special Surgery Knee Score (HSS) score

    The Hospital for Special Surgery Knee Score (HSS) is a patient-reported questionnaire specific to the knee joint, with a total score of 100 points. It comprises six scoring components: pain (30 points), function (22 points), range of motion (18 points), muscle strength (10 points), knee deformity (10 points) and stability (10 points). Additional points are deducted for the use of assistive devices, extension lag and varus deformity: up to 3 points for assistive device use, up to 5 points for extension lag and 1 point deducted for every 5 degrees of varus deformity. The scores are classified as follows: ≥ 85 as "Excellent", 70-84 as "Good", 60-69 as "Fair", and \< 60 as "Poor". The HSS score is widely praised for its perceived ease of use and quick recording and has been shown to be an effective and reliable measure for assessing the efficacy of TKA.

    preoperative and two-year follow-up

Secondary Outcomes (4)

  • Range of motion

    preoperative and two-year follow-up

  • Visual Analogue Scale (VAS) score

    preoperative and two-year follow-up

  • Pathogens Type

    preoperative and two-year follow-up

  • SF-12 score

    preoperative and two-year follow-up

Study Arms (2)

DAIR group

Patients with acute/hematogenous uPJI underwent debridement, antibiotics and implant retention (DAIR)

Revision group

Patients with chronic uPJI underwent revision.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty-seven patients (28 knees) diagnosed with uPJI from 2017 to 2024 were analyzed. MARS-MRI and intraoperative direct vision were used to confirm the extent of lesions. All patients completed at least one year of follow-up. Follow-up comprised comprehensive orthopaedic examinations and serological tests, supplemented by repeat imaging where necessary to assess local fracture/internal fixation status.

You may qualify if:

  • Diagnosis of uPJI on the basis of medical history, symptoms, imaging data, etc.;
  • Treatment by internal fixation surgery;
  • Normal cognitive function;
  • Informed consent obtained from the patient or family.

You may not qualify if:

  • Significant missing data: In accordance with the Transparent Reporting of a Multivariate Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement, only cases with complete key variables (missing rate \<5%) were included;
  • Severe preoperative systemic comorbidities (e.g., decompensated liver/renal failure, active pneumonia, malignancy, and cachexia) and/or a history of mental illness;
  • Missing postoperative follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy chief physician

Study Record Dates

First Submitted

September 21, 2025

First Posted

October 6, 2025

Study Start

June 1, 2017

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

October 6, 2025

Record last verified: 2025-09

Locations