Assessment of Anterior Cruciate Ligament (ACL) Degeneratio Mucosa Treatment

NCT05701579 | Recruiting

• 1 other identifier: 1-pro-ar-2023
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (5)

• Range of motion

  Range of motion assessed by the means of goniometer

  At the 12 month of the follow-up

• Range of motion

  Range of motion assessed by the means of goniometer

  At the 24 month of the follow-up

• Knee anterior translatory stability

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

  At the 12 month of the follow-up

• Knee anterior translatory stability

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

  At the 24 month of the follow-up

• Knee anterolateral rotational stability

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

  At the 24 month of the follow-up

Secondary Outcomes (4)

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

  At the 12 month of the follow-up

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

  At the 24 month of the follow-up

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

  At the 12 month of the follow-up

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

  At the 24 month of the follow-up

Study Arms (1)

Patients with ACL Degeneratio Mucosa

Patients with ACL Degeneratio Mucosa

Procedure: ACL "decompression"

Interventions

ACL "decompression" PROCEDURE

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

Patients with ACL Degeneratio Mucosa

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ACL degeneratio mucosa decided to undergo a surgical treatment

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Artromedical Konrad Malinowski Clinic: lead

Study Sites (1)

Artromedical Orthopaedic Clinic

Bełchatów, Łódź Voivodeship, 97-400, Poland

RECRUITING

Related Publications (4)

• Gersing AS, Schwaiger BJ, Nevitt MC, Joseph GB, Feuerriegel G, Jungmann PM, Guimaraes JB, Facchetti L, McCulloch CE, Makowski MR, Link TM. Anterior cruciate ligament abnormalities are associated with accelerated progression of knee joint degeneration in knees with and without structural knee joint abnormalities: 96-month data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2021 Jul;29(7):995-1005. doi: 10.1016/j.joca.2021.03.011. Epub 2021 Mar 26.

  PMID: 33775919 BACKGROUND

• Lintz F, Pujol N, Boisrenoult P, Bargoin K, Beaufils P, Dejour D. Anterior cruciate ligament mucoid degeneration: a review of the literature and management guidelines. Knee Surg Sports Traumatol Arthrosc. 2011 Aug;19(8):1326-33. doi: 10.1007/s00167-011-1433-0. Epub 2011 Feb 18.

  PMID: 21331652 BACKGROUND

• Sweed T, Mussa M, El-Bakoury A, Geutjens G, Metcalfe A. Management of mucoid degeneration of the anterior cruciate ligament: a systematic review. Knee Surg Relat Res. 2021 Aug 21;33(1):26. doi: 10.1186/s43019-021-00110-6.

  PMID: 34419162 BACKGROUND

• Lee JW, Ahn JT, Gwak HG, Lee SH. Clinical Outcomes of Arthroscopic Notchplasty and Partial Resection for Mucoid Degeneration of the Anterior Cruciate Ligament. J Clin Med. 2021 Jan 16;10(2):315. doi: 10.3390/jcm10020315.

  PMID: 33467062 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Konrad Malinowski, MD PhD

  Artromedical Orthopaedic Clinic, Bełchatów, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konrad Malinowski, MD PhD

CONTACT

+48 509812212; malwin8@wp.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Konrad Malinowski MD, Director of Artromedical Konrad Malinowski Clinic and Principal Investigator

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 27, 2023
• Study Start: July 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

PL (1)