Assessment of Anterior Cruciate Ligament (ACL) Degeneratio Mucosa Treatment
January 25, 2023 updated by: Konrad Malinowski MD, Artromedical Konrad Malinowski Clinic
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Konrad Malinowski, MD PhD
- Phone Number: +48 509812212
- Email: malwin8@wp.pl
Study Locations
-
-
Łódzkie
-
Bełchatów, Łódzkie, Poland, 97-400
- Recruiting
- Artromedical Orthopaedic Clinic
-
Contact:
- Konrad Malinowski, MD PhD
- Phone Number: +48 509 812 212
- Email: malwin8@wp.pl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with ACL degeneratio mucosa decided to undergo a surgical treatment
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with ACL Degeneratio Mucosa
|
The technique of ACL "decompression" by the means of longitudinal incisions and evacuation of extrafibrous mucoid tissue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion
Time Frame: At the 12 month of the follow-up
|
Range of motion assessed by the means of goniometer
|
At the 12 month of the follow-up
|
|
Range of motion
Time Frame: At the 24 month of the follow-up
|
Range of motion assessed by the means of goniometer
|
At the 24 month of the follow-up
|
|
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.
|
At the 12 month of the follow-up
|
|
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.
|
At the 24 month of the follow-up
|
|
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
|
At the 24 month of the follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
At the 12 month of the follow-up
|
|
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
|
At the 24 month of the follow-up
|
|
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
|
At the 12 month of the follow-up
|
|
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
|
At the 24 month of the follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Anticipated)
December 31, 2025
Study Completion (Anticipated)
December 31, 2026
Study Registration Dates
First Submitted
January 6, 2023
First Submitted That Met QC Criteria
January 25, 2023
First Posted (Actual)
January 27, 2023
Study Record Updates
Last Update Posted (Actual)
January 27, 2023
Last Update Submitted That Met QC Criteria
January 25, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-pro-ar-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.