Assessment of Outcomes of Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR)

Recruiting

• Conditions: Posterior Cruciate Ligament Tear
• Interventions: Procedure: DB-PCLR

• Registration Number: NCT05701592
• Lead Sponsor: Konrad Malinowski MD

Brief Summary

Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR) is becoming increasingly used alternative to the single-bungle PCLR. While more technically challenging, it seems to better improve patients' outcomes. Therefore, outcomes of DB-PCLR will be assessed and reported.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Status Verified: 2023-01
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-25
• Last Update Submitted: 2023-01-25
• Study First Posted: 2023-01-27
• Last Update Posted: 2023-01-27
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• PCL tear with III grade sympomatic posterior instability confirmed clinically and radiologically
• full knee range of motion

Exclusion Criteria

• active knee inflammation
• non-adherence to the study protocol
• fixed posterior drawer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PCL tear treated with DB-PCLR	DB-PCLR	Patients with PCL tear treated with DB-PCLR

Primary Outcome Measures

Name	Time	Method
Knee posterior translatory stability - stress X-ray	At the 24 month of the follow-up.	Stress X-ray assessing posterior translatory stability of the knee will be performed and outcomes will be presented in milimeters
Knee posterior translatory stability - posterior Lachman test	At the 24 month of the follow-up.	Posterior Lachman test aided with Rollimeter will be performed and outcomes will be presented in milimeters
Knee posterior translatory stability - posterior sag test	At the 24 month of the follow-up.	Posterior sag test will be performed and outcome will be presented as present/ absent
Knee posterior translatory stability - posterior drawer test	At the 24 month of the follow-up.	Posterior drawer test aided with Rollimeter will be performed and outcomes will be presented in milimeters
Knee internal rotation stability	At the 24 month of the follow-up.	Maximal knee internal rotation angle will be assessed with different angles of knee flexion and measured by the means of goniometer and outcomes will be presented in degrees

Secondary Outcome Measures

Name	Time	Method
The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)	At the 24 month of the follow-up.	Min of 0 max of 100 points, higher scores mean a better outcome
Retear rate	At the 24 month of the follow-up.	Rate of patients with retear of the reconstructed ligament
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)	At the 24 month of the follow-up.	Min of 0 max of 87 points, higher scores mean a better outcome
ROM	At the 24 month of the follow-up.	Knee range of motion assessed by the means of goniometer.

Trial Locations

Locations (1)

Artromedical Orthopaedic Clinic; 🇵🇱 Bełchatów, Łódzkie, Poland