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A Multicenter, Randomized, Single-Blind, Parallel-Controlled Study on the Safety and Efficacy of the Novel Internal Tension-Relieving Augmentation System for Posterior Cruciate Ligament Reconstruction

A Multicenter, Randomized, Single-Blind, Parallel-Controlled Study on the Safety and Efficacy of the Novel Internal Tension-Relieving Augmentation System for Posterior Cruciate Ligament Reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120656
Enrollment
Unknown
Registered
2026-03-18
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosed with posterior cruciate ligament injury of the knee

Interventions

Tension-Relieving Augmentation Reconstruction Group:To perform arthroscopic anatomical PCL reconstruction by weaving a Novel Internal Tension-Relieving Augmentation System into the tendon graft

Sponsors

The First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1.Male or female, aged 18 to 50 years inclusive. 2.Meet the diagnostic criteria for PCL injury as outlined in the 2021 International Consensus on Posterior Cruciate Ligament Injuries (ICON). 3.Posterior cruciate ligament (PCL) injury of the knee associated with meniscal injury. 4.Patients who are scheduled for arthroscopic anatomical posterior cruciate ligament reconstruction. 5.The patient is generally healthy, has no significant chronic medical history, and is considered able to tolerate the surgical procedure. 6.There are no extra-articular comorbidities or joint deformities. 7.Adult subjects have consented to participate in this trial and have signed the Informed Consent Form. 8.Is willing to comply with all prohibitions and restrictions specified in this study protocol. 9.The patient participated voluntarily, provided signed informed consent, and demonstrated good compliance;

Exclusion criteria

Exclusion criteria: 1.including knee joint infection, gouty arthritis, or rheumatoid arthritis. 2.Presence of knee stiffness or ankylosis. 3.With severe coagulopathy and/or bleeding disorders; 4.With severe osteoporosis; 5.concomitant neurological injury or severe muscle atrophy around the knee; 6.With concomitant fracture and/or severe chondral lesion. 7.Multiple ligament injury of the knee. 8.Significant comorbidities (e.g., CAD, hypertension, diabetes, gout) that would preclude safe surgery. 9.Subjects with incomplete follow-up or those lost to follow-up; 10.Patients who have undergone open knee surgery within the past 6 months. 11.Pregnant or lactating women, women planning pregnancy, or those with a positive baseline pregnancy test. 12.Patients with underlying infectious, inflammatory, or metabolic arthritis of the knee; 13.Concurrent participation in another trial within the last 3 months or premature discontinuation from a prior trial; 14.Other conditions that make the subject ineligible for participation at the investigator’s discretion.

Design outcomes

Primary

MeasureTime frame
Lysholm Knee Scoring Scale;Tegner Activity Scale Score;Knee MRI data;IKDC Subjective Knee Form;

Secondary

MeasureTime frame
Visual Analogue Scale Score;Posterior Cruciate Ligament – Return to Sport after Injury (PCL-RSI) scale;

Countries

China

Contacts

Public ContactYanlin Li

The First Affiliated Hospital of Kunming Medical University

liyanlin@kmmu.edu.cn+86 871 65324888

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026