Prosthetic Joint InfectionNCT07208968
Metal Artifact Reduction Sequence MRI for Surgical Decision-Making in Infected Unicompartmental Knee Arthroplasty
An observational study of Prosthetic Joint Infection and Unicompartmental Knee Arthroplasty, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Prosthetic Joint Infection, Unicompartmental Knee Arthroplasty
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 30 Jun 2023
- Phase
- Observational
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
About this study
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.
Read the detailed description
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 (infection control and functional recovery) of uPJI patients in a single PJI center.
- Keywords
- Prosthetic joint infection, Unicompartmental knee arthroplasty, Antibiotics and implant retention, One-stage revision, Unicompartmental spacer, Metal artefact reduction sequence magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DAIR group | Patients with acute/hematogenous uPJI underwent debridement, antibiotics and implant retention (DAIR) | |
| Revision group | Patients with chronic uPJI underwent revision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: preoperative and two-year follow-up
Secondary outcomes (4)
Range of motion
Measured: preoperative and two-year follow-up
Visual Analogue Scale (VAS) score
VAS scores are the most commonly used indicator for assessing the intensity of patient pain. The scale ranges from "0" to "10", where "0" indicates no pain and "10" represents the most severe pain that is unbearable. Patients will rate their pain based on subjective perceptions. In this trial, VAS scores will be recorded once before TKA. The VAS scores will be assessed separately for the resting and flexion states. If the patient's hospitalization period is shorter than 72 hours, the VAS score at discharge will be recorded instead of that at 72 hours. Studies have shown that some patients still experience joint pain six months after TKA. The VAS scores of patients at 6 months after TKA will be evaluated. A VAS score of 4 or above is defined as "chronic persistent pain after TKA." The results will be used to evaluate whether PSIA can reduce pain after TKA.
Measured: preoperative and two-year follow-up
Pathogens Type
The pathogen that caused the patient's current infection was finally identified through culture.
Measured: preoperative and two-year follow-up
SF-12 score
SF-12 (12-Item Short Form Health Survey) is a health-related quality of life (HRQoL) assessment tool. It consists of 12 items, mainly covering two core aspects: PCS (Physical Component Summary, summary of physical health) and MCS (Mental Component Summary, summary of mental health). The dimensions covered include: physical function (PF), limitations in daily activities (RP), physical pain (BP), overall health (GH), vitality (VT), social function (SF), emotional role function (RE), and mental health (MH). It enables the assessment of patients' overall health status within a relatively short period of time. It is often used to evaluate the changes in patients' quality of life before and after orthopedic surgeries (such as joint replacement, spinal surgery, ligament reconstruction, etc.). The range value is 0 to 100. Higher scores mean a better outcome.
Measured: preoperative and two-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Jun 2017
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Fang, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208968
- Sponsor's protocol ID
- MTCA,ECFAH Of FMU [2015]084 -1
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No