Comparison of tibial eminence fracture treatments Musculoskeletal Diseases
Conditions
Interventions
This trial is a single-center, prospective, parallel group, randomized controlled superiority trial without crossover, factorial or single-arm design. Participants are allocated 1:1 to an intervention
surgeons cannot be blinded because of the distinct surgical instruments and procedures involved, and therefore they are excluded from follow-up scoring and statistical analysis. Randomization and allo
a 5-minute break was mandatory if the limit was exceeded. A STORZ 30° arthroscope system with 60 mmHg normal saline irrigation pressure was used for all cases. Preoperative X-ray and 3D CT were perfor
Sponsors
Changji Hui Autonomous Prefecture Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years old, any gender 2. Diagnosed with fresh Meyers–McKeever type II or III tibial eminence fracture 3. Surgery performed within 14 days after injury without mature callus formation 4. ASA physical status grade I or II 5. Normal cognitive and mental status, capable of completing full rehabilitation and outpatient follow-up 6. Fully informed of trial content and voluntarily signed informed consent 7. No high risk of loss to follow-up, such as relocation
Exclusion criteria
Exclusion criteria: 1. Combined ipsilateral multi-ligament rupture, grade III meniscus tear, femoral or tibial plateau fracture 2. Severe osteoporosis, defined as DXA T-score = -2.5 3. Continuous oral glucocorticoid administration for at least 4 months within the past 6 months 4. Prior ipsilateral knee surgery, Kellgren-Lawrence grade II or higher osteoarthritis 5. Coagulopathy, systemic active infection, preoperative fever above 38.5°C 6. Pregnant, lactating females or women planning pregnancy within 6 months 7. Severe cognitive impairment or mental illness, unable to cooperate with follow-up and rehabilitation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical function measured using the Patient-Reported Outcomes Measurement Information System Physical Function Computer Adaptive Test (PROMIS PF-CAT) at baseline, 3, 6, 12 and 18 months post-randomization | — |
Countries
China
Contacts
Public ContactXin Guo
Outcome results
None listed