NCT06918171

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

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

March 15, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

15 days

First QC Date

March 29, 2025

Last Update Submit

April 7, 2025

Conditions

Keywords

fracture fixationRetrospective study

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale Score

    The Visual Analog Scale (VAS) Score is used to assess the intensity of pain experienced by patients. The VAS is a continuous scale comprising a 100-mm line, where the minimum value is 0 (representing no pain) and the maximum value is 10 (representing the worst imaginable pain). A higher score indicates a worse outcome, reflecting greater pain intensity. The mean VAS score across all participants will be reported to evaluate the average pain level at 6 months post-surgery.

    6 months after surgery

  • Lysholm Knee Scoring Scale

    The Lysholm Knee Scoring Scale is used to evaluate knee function and symptoms. The scale ranges from a minimum value of 0 to a maximum value of 100. A higher score indicates a better outcome, reflecting improved knee function and fewer symptoms. The scale assesses factors such as pain, instability, locking, swelling, and the ability to perform activities like climbing stairs or squatting. The mean Lysholm score across all participants will be reported to evaluate the average knee function at 6 months post-surgery.

    6 months after surgery

  • International Knee Documentation Committee Score

    The International Knee Documentation Committee (IKDC) Score is used to evaluate knee function, symptoms, and the ability to engage in sports activities following surgery. The IKDC Score ranges from a minimum value of 0 to a maximum value of 100. A higher score indicates a better outcome, reflecting improved knee function, fewer symptoms, and better overall knee health. The score assesses aspects such as pain, swelling, knee stability, and the ability to perform daily activities and sports. The mean IKDC score across all participants will be reported to evaluate the average knee function and sports activity level at 6 months post-surgery.

    6 months after surgery

  • Range of Motion

    The Range of Motion (ROM) of the knee is measured to assess the degree of knee flexion and extension following surgery. ROM is evaluated using a goniometer, with measurements recorded in degrees. The minimum value for knee flexion is 0 degrees (indicating no flexion, i.e., a fully extended knee), and the maximum value can reach up to approximately 135 degrees in a healthy knee (indicating full flexion). For extension, the minimum value is 0 degrees (full extension), while negative values (e.g., -5 degrees) may indicate an extension deficit. A greater ROM, particularly in flexion, indicates a better outcome, reflecting improved knee mobility and function. The mean flexion and extension angles across all participants will be reported to evaluate the average knee mobility at 6 months post-surgery.

    6 months after surgery

Study Arms (1)

Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation

EXPERIMENTAL

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

Procedure: Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation

Interventions

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

Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Suzhou, Jiangsu, 252000, China

Location

MeSH Terms

Conditions

Tibial Plateau Fractures

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesTibial FracturesKnee InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 9, 2025

Study Start

March 15, 2025

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Locations