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NCT Number: NCT05701579

Assessment of Anterior Cruciate Ligament (ACL) Degeneratio Mucosa Treatment

Anterior Cruciate Ligament (ACL) Degeneratio Mucosa is a condition resulting from mucoid degeneration of ACL. Exact etiology is unknown, however ACL Degeneratio Mucosa impairs everyday functioning. In the literature there were some reports of treatment by ACL excision and subsequent reconstruction, however such treatment brings risk of deteriorated function. In this study the investigator will evaluate the technique of ACL "decompression" by the means of longitudinal incisions and evacuation of extrafibrous mucoid tissue.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

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

  • patients with ACL degeneratio mucosa decided to undergo a surgical treatment
  • range of motion impairment caused by mucoid or cystic changes in ACL confirmed by MRI

Exclusion criteria

  • non-adherence to the study protocol
  • active knee inflammation
  • range of motion impairment due to other extra- and intra-articular reasons

Treatment and study plan

ACL "decompression"

Procedure

The technique of ACL "decompression" by the means of longitudinal incisions and evacuation of extrafibrous mucoid tissue.

Primary outcomes

  1. Range of motion

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

    Range of motion assessed by the means of goniometer

  2. Range of motion

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

    Range of motion assessed by the means of goniometer

  3. Knee anterior translatory stability

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

    Knee stability assessed by the means of Rollimeter-aided Lachman test - results will be presented in milimeters.

  4. Knee anterior translatory stability

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

    Knee stability assessed by the means of Rollimeter-aided Lachman test - results will be presented in milimeters.

  5. Knee anterolateral rotational stability

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

    Knee stability assessed by the means of pivot-shift test - results will be presented in grades

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

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

Artromedical Konrad Malinowski Clinic

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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