Multicenter Clinical Study on Robotic-Assisted Surgical Management of Posterior Cruciate Ligament Tibial Avulsion Fractures

NCT07575256 | Not Yet Recruiting

• 1 other identifier: 26490-4-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical trial is to evaluate the efficacy of robotic-assisted surgery in the management of posterior cruciate ligament (PCL) avulsion fractures involving the tibial insertion site of the cruciate ligament. Specifically, the study seeks to determine: (1) whether robotic-assisted surgery yields superior anatomical reduction accuracy-particularly in restoring the native position of the tibial avulsion fragment-compared with conventional open reduction and internal fixation (ORIF); and (2) whether such improved precision translates into enhanced long-term functional recovery of the knee joint.

Conditions

PCL - Posterior Cruciate Ligament Deficiency; Posterior Cruciate Ligament Tear; PCL - Posterior Cruciate Ligament Rupture

Keywords

Posterior Cruciate Ligament tibial avulsion fractures; Robot-assisted surgery

Outcome Measures

Primary Outcomes (1)

• the quality of surgical reduction

  In the CT scan images obtained approximately 72 hours (±24 hours) after the surgery, the maximum distance between the fracture fragments was measured on the sagittal plane.

  72 hours (±24 hours) after the surgery

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

Perform surgical robot-assisted arthroscopic surgery

Procedure: Surgical robot-assisted arthroscopic surgery

Control group

OTHER

Traditional posterior incision reduction and internal fixation surgery is performed

Procedure: Open reduction and internal fixation surgery

Interventions

Surgical robot-assisted arthroscopic surgery PROCEDURE

Experimental group: Robot-assisted arthroscopic surgery

Experimental group

Open reduction and internal fixation surgery PROCEDURE

Control group: incisional reduction and internal fixation surgery

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Acute closed tibial avulsion fracture, with surgery performed within 3 weeks of injury ③ Radiographically confirmed Meyers-McKeever classification Type II or III fracture ④ Absence of absolute contraindications to surgical intervention ⑤ Provision of voluntary, written informed consent prior to enrollment

You may not qualify if:

• Pathological fractures or complex ipsilateral injuries, including concomitant fractures at other anatomical sites.
• Prior ipsilateral knee joint surgery. ③. Significant vascular or neurological compromise.
• Acute meniscal tears, acute anterior cruciate ligament (ACL) ruptures, or acute injuries to the medial or lateral collateral ligaments.
• Compromised local soft tissue integrity, including open fractures. ⑥. Withdrawal from the study or loss to follow-up despite having provided written informed consent.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Interventions

Open Fracture Reduction

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Yu Jia-kuo

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Jia-kuo, MD，Phd

CONTACT

+86 133 3103 1448; yujiakuo@tsinghua.edu.cn

Liu Kui, MD

CONTACT

+86 15932650850; liukui8153@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Surgery

Model Details: Group A: Robot-assisted surgery group (experimental group) Group B: Open reduction and internal fixation group (control group)

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The original data will be transferred to the collaborating research team within 12 months following the completion of the clinical trial and will remain accessible to them for a period of two years.
• Access Criteria: Within a defined timeframe following the conclusion of the trial, the collaborative research team may access the data repository and share de-identified data-including treatment records, follow-up assessments, and laboratory results-via secure data transmission methods. Any use of such data requires prior written agreement from the Principal Investigator and formal approval from the relevant Ethics Committee, and is strictly limited to scientific research purposes.

Locations

CN (1)