Clinical Efficacy of Open Reduction and Suture Bridge Fixation for PCL Tibial Avulsion Fractures

NCT ID: NCT06918171

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-03-30

Brief Summary

Abstract Background: Posterior cruciate ligament (PCL) tibial avulsion fractures significantly impair knee function; however, optimal surgical fixation approaches are not agreed upon. The investigators performed this study to compare the clinical outcomes of PCL tibial avulsion fractures treated with open reduction and anchor suture bridge fixation.

Methods: A total of 17 patients underwent open reduction and anchor suture bridge fixation following injury. The investigators recorded operation time, intraoperative and postoperative complications, and used imaging to assess fracture reduction and healing. Visual Analog Scale (VAS), Lysholm Knee Scoring Scale, International Knee Documentation Committee (IKDC) score, and knee range of motion (ROM) were evaluated preoperatively, 3 months postoperatively, and at final follow-up.

Detailed Description

Patient Selection This study was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University. The ethics number was: JD-HG-2025-035. From January 2019 to December 2023, patients diagnosed with PCL tibial avulsion fractures and treated with open reduction combined with anchor fixation at our center were evaluated for inclusion. Inclusion criteria were: (1) a clear diagnosis of PCL tibial avulsion fracture verified through preoperative radiographs and computed tomography (CT), with classification as type II or III based on the Griffith system (a modified Meyers and McKeever scale)[16]; (2) patients aged 18 years or older; (3) surgical management within two weeks post-injury; and (4) absence of additional ligament or meniscal injuries in the affected knee. Exclusion criteria were: (1) concurrent ligament or meniscal injuries confirmed via magnetic resonance imaging (MRI); (2) prior surgical procedures or traumatic injuries involving the same knee; (3) severe systemic diseases that could interfere with surgical outcomes; and (4) insufficient clinical or radiographic follow-up data. In total, 17 patients (9 males and 8 females), with an average age of 49 ± 12 years, who satisfied all inclusion and exclusion criteria, were ultimately included for analysis.

Surgical Techniques All surgeries were carried out by the same experienced orthopedic surgeon to ensure procedural consistency. Under general anesthesia, patients were positioned prone, and a midline posterior incision was made at the level of the popliteal fossa. After incising the fascia, careful dissection was undertaken to expose the posterior joint capsule and fracture fragment, with particular attention to safeguarding the neurovascular structures. Once the fracture site was fully exposed, hematoma and any interposing soft tissue were meticulously cleared to prepare for reduction. The avulsed bone fragment, located at the PCL insertion site, was identified and prepared for fixation. A suture anchor (Johnson & Johnson, USA) was carefully implanted into the prepared osseous bed. The suture threads were passed anteriorly around the PCL and configured in a figure-of-eight pattern to achieve precise anatomical reduction of the fracture fragment. To enhance fixation stability, two extracortical anchors (Johnson & Johnson, USA) were additionally positioned approximately 2 cm distal to the fracture site, securing the suture construct effectively. Intraoperative fluoroscopy was utilized to verify proper fracture reduction and secure fixation. Upon confirmation, the surgical site was irrigated, hemostasis was achieved, and the incision was closed in layers.

Postoperative Management Postoperatively, all patients were immobilized with a hinged knee brace locked in full extension for the initial 2 weeks, and partial weight-bearing with crutches was permitted as tolerated. Passive knee range-of-motion exercises (0°-60°) were initiated under supervised rehabilitation 2 weeks after surgery. At 4-6 weeks postoperatively, progressive weight-bearing was encouraged according to fracture healing confirmed by radiographic assessment, and knee flexion was gradually increased (0°-90°). After 8 weeks, patients transitioned to full weight-bearing, and active muscle strengthening and proprioception training programs were initiated.

Clinical Assessments Clinical outcomes were comprehensively assessed at three distinct time points: prior to surgery, at 3 months postoperatively, and at the final follow-up visit. The key evaluation parameters included pain intensity, knee joint function, range of motion (ROM), fracture healing, and postoperative complications. Pain severity was quantified using the Visual Analog Scale (VAS; 0-10 points), where 0 indicates no pain and 10 represents the worst possible pain. Functional outcomes were evaluated with two well-established scoring systems: the Lysholm Knee Scoring Scale (ranging from 0 to 100, where higher scores indicate better knee function) and the International Knee Documentation Committee (IKDC) subjective knee assessment (also ranging from 0 to 100, with higher values reflecting superior functional status). Knee ROM, encompassing both maximal flexion and extension, was measured using a standard goniometer. Fracture union was assessed via routine anteroposterior and lateral radiographs, with successful healing defined as the presence of continuous cortical alignment and trabecular bridging at the fracture site, without detectable fracture lines. In addition, any postoperative complications, including infection, neurovascular injuries, hardware-related issues, implant discomfort, or the necessity for reoperation, were meticulously documented during each follow-up assessment.

Statistical Analysis Statistical analyses were conducted using SPSS software (version 26.0). Continuous variables were expressed as mean ± standard deviation (SD) or as median with interquartile range (IQR), depending on the data distribution. The Shapiro-Wilk test was applied to examine the normality of continuous variables. Comparisons of clinical outcomes, including VAS pain scores, Lysholm knee scores, IKDC scores, and knee range of motion (ROM), across preoperative and postoperative time points were evaluated using the Friedman test for repeated measures, with Wilcoxon signed-rank tests employed for post hoc pairwise comparisons. Categorical variables, such as complication rates, were summarized as frequencies and percentages. A P-value < 0.05 was considered indicative of statistical significance in all analyses.

Conditions

Tibial Plateau Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation

Under general anesthesia, patients were positioned prone, and a midline posterior incision was made at the level of the popliteal fossa. After incising the fascia, careful dissection was undertaken to expose the posterior joint capsule and fracture fragment, with particular attention to safeguarding the neurovascular structures. Once the fracture site was fully exposed, hematoma and any interposing soft tissue were meticulously cleared to prepare for reduction. The avulsed bone fragment, located at the PCL insertion site, was identified and prepared for fixation. A suture anchor (Johnson \& Johnson, USA) was carefully implanted into the prepared osseous bed. The suture threads were passed anteriorly around the PCL and configured in a figure-of-eight pattern to achieve precise anatomical reduction of the fracture fragment. To enhance fixation stability, two extracortical anchors (Johnson \& Johnson, USA) were additionally positioned approximately 2 cm distal to the fracture site, securin

Group Type: EXPERIMENTAL

Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation

Intervention Type: PROCEDURE

Under general anesthesia, patients were positioned prone, and a midline posterior incision was made at the level of the popliteal fossa. After incising the fascia, careful dissection was undertaken to expose the posterior joint capsule and fracture fragment, with particular attention to safeguarding the neurovascular structures. Once the fracture site was fully exposed, hematoma and any interposing soft tissue were meticulously cleared to prepare for reduction. The avulsed bone fragment, located at the PCL insertion site, was identified and prepared for fixation. A suture anchor (Johnson \& Johnson, USA) was carefully implanted into the prepared osseous bed. The suture threads were passed anteriorly around the PCL and configured in a figure-of-eight pattern to achieve precise anatomical reduction of the fracture fragment. To enhance fixation stability, two extracortical anchors (Johnson \& Johnson, USA) were additionally positioned approximately 2 cm distal to the fracture site, securing

Interventions

Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation

Under general anesthesia, patients were positioned prone, and a midline posterior incision was made at the level of the popliteal fossa. After incising the fascia, careful dissection was undertaken to expose the posterior joint capsule and fracture fragment, with particular attention to safeguarding the neurovascular structures. Once the fracture site was fully exposed, hematoma and any interposing soft tissue were meticulously cleared to prepare for reduction. The avulsed bone fragment, located at the PCL insertion site, was identified and prepared for fixation. A suture anchor (Johnson \& Johnson, USA) was carefully implanted into the prepared osseous bed. The suture threads were passed anteriorly around the PCL and configured in a figure-of-eight pattern to achieve precise anatomical reduction of the fracture fragment. To enhance fixation stability, two extracortical anchors (Johnson \& Johnson, USA) were additionally positioned approximately 2 cm distal to the fracture site, securing

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• A clear diagnosis of posterior cruciate ligament (PCL) tibial avulsion fracture, verified through preoperative radiographs and computed tomography (CT), with classification as type II or III based on the Griffith system (a modified Meyers and McKeever scale).
• Patients aged 18 years or older.
• Surgical management within two weeks post-injury.
• Absence of additional ligament or meniscal injuries in the affected knee, confirmed via magnetic resonance imaging (MRI).

Exclusion Criteria

• Concurrent ligament or meniscal injuries in the affected knee, confirmed via MRI.
• Prior surgical procedures or traumatic injuries involving the same knee.
• Severe systemic diseases that could interfere with surgical outcomes (e.g., uncontrolled diabetes, severe cardiovascular disease).
• Insufficient clinical or radiographic follow-up data.

Additional Information:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The medical record system and imaging system of the Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

JD-HG-2025-035

Identifier Type: -

Identifier Source: org_study_id