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NCT Number: NCT05701592

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

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.

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Key information

Conditions

Posterior Cruciate Ligament Tear

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Artromedical Orthopaedic Clinic

Bełchatów, Łódź Voivodeship, 97-400, Poland

Location status: Recruiting

Location contact

Konrad Malinowski, MD PhD

CONTACT

[email protected]

+48 509 812 212

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DB-PCLR

Procedure

DB-PCLR with reconstruction of both PCL bundles: anterolateral and posteromedial bundle will be performed.

Primary outcomes

  1. Knee posterior translatory stability - posterior sag test

    Time frame: At the 12 month of the follow-up.

    Posterior sag test will be performed and outcome will be presented as present/ absent

  2. Knee posterior translatory stability - posterior drawer test

    Time frame: At the 12 month of the follow-up.

    Posterior drawer test aided with Rollimeter will be performed and outcomes will be presented in milimeters

  3. Knee posterior translatory stability - posterior Lachman test

    Time frame: At the 12 month of the follow-up.

    Posterior Lachman test aided with Rollimeter will be performed and outcomes will be presented in milimeters

  4. Knee posterior translatory stability - stress X-ray

    Time frame: At the 12 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

  5. Knee internal rotation stability

    Time frame: At the 12 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

  6. Knee posterior translatory stability - posterior sag test

    Time frame: At the 24 month of the follow-up.

    Posterior sag test will be performed and outcome will be presented as present/ absent

  7. Knee posterior translatory stability - posterior drawer test

    Time frame: At the 24 month of the follow-up.

    Posterior drawer test aided with Rollimeter will be performed and outcomes will be presented in milimeters

  8. Knee posterior translatory stability - posterior Lachman test

    Time frame: At the 24 month of the follow-up.

    Posterior Lachman test aided with Rollimeter will be performed and outcomes will be presented in milimeters

  9. Knee posterior translatory stability - stress X-ray

    Time frame: 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

  10. Knee internal rotation stability

    Time frame: 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 outcomes

  1. The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)

    Time frame: At the 12 month of the follow-up.

    Min of 0 max of 87 points, higher scores mean a better outcome

  2. The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)

    Time frame: At the 24 month of the follow-up.

    Min of 0 max of 87 points, higher scores mean a better outcome

  3. The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: At the 12 month of the follow-up.

    Min of 0 max of 100 points, higher scores mean a better outcome

  4. The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: At the 24 month of the follow-up.

    Min of 0 max of 100 points, higher scores mean a better outcome

  5. Retear rate

    Time frame: At the 12 month of the follow-up.

    Rate of patients with retear of the reconstructed ligament

  6. Retear rate

    Time frame: At the 24 month of the follow-up.

    Rate of patients with retear of the reconstructed ligament

  7. ROM

    Time frame: At the 12 month of the follow-up.

    Knee range of motion assessed by the means of goniometer.

  8. ROM

    Time frame: At the 24 month of the follow-up.

    Knee range of motion assessed by the means of goniometer.

Study contacts

Contact information is provided by the study sponsor or research team.

Konrad Malinowski, MD PhD

CONTACT

[email protected]

+48 509812212

Sponsors and collaborators

Lead sponsor

Konrad Malinowski MD

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 27, 2023
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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