Clinical trial NCT06736639: Morphological Characteristics of Inferior Pole Patellar Fractures and a Finite Element Analysis Combined with a Retrospective Clinical Study of Anchor Suture and Titanium Cable Cerclage Treatment
Official title: Morphological Characteristics of Inferior Pole Patellar Fractures and a Finite Element Analysis Combined with a Retrospective Clinical Study of Anchor Suture and Titanium Cable Cerclage Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inferior Patellar Fracture
Fracture Maps
Finite Element Analysis
Keywords: Inferior Patellar Fracture
Fracture Maps
Finite Element Analysis
Retrospective Study
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 57
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients diagnosed with inferior pole patellar fractures (IPPF), confirmed through X-ray or CT imaging, and aged between 18 and 70 years. Eligible participants include individuals with isolated inferior pole patellar fractures who meet the inclusion criteria. Patients with concomitant fractures of other parts of the knee, open fractures, or pathological fractures are excluded to ensure a homogenous study population. This population represents a clinically relevant group for evaluating the outcomes of surgical interventions for IPPF.

Brief summary: The goal of this study is to compare the biomechanical stability and clinical outcomes of two treatment methods for inferior pole patellar fractures (IPPF): anchor suture with patellar cerclage and Kirschner-wire tension band combined with patellar cerclage. The study involves patients with IPPF, focusing on fracture patterns and treatment outcomes.

1. Undergo retrospective analysis of fracture patterns using fracture mapping.
2. Participate in biomechanical analysis via finite element modeling of both treatment methods.
3. Be part of a clinical comparison between two surgical treatments based on operative time, postoperative complications, and functional outcomes.


Eligibility criteria: Inclusion Criteria:

(1) diagnosis of IPPF confirmed by X-ray or CT, and (2) patients aged between 18 and 70 years.

Exclusion Criteria:

(1) concomitant fractures of other parts of the knee, (2) open fractures, and (3) pathological fractures.

Primary outcomes:
measure: final knee range of motion
timeFrame: 6 months to 1.5 years after surgery
measure: incidence of secondary surgery
timeFrame: 6 months to 1.5 years after surgery
measure: postoperative complications
timeFrame: 6 months to 1.5 years after surgery
Secondary outcomes:
measure: operative time
timeFrame: 6 months to 1.5 years after surgery
measure: functional recovery
timeFrame: 6 months to 1.5 years after surgery
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The medical record system and imaging system of the Second Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: