Artromedical Orthopaedic Clinic
Bełchatów, Łódź Voivodeship, 97-400, Poland
Location status: Recruiting
Recruiting
NCT Number: NCT05868434
MPFLR With Fascia Lata Allograft, Based on Isometry Assessment + Elmslie-Trillat TTO
The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Medial Patellofemoral Ligament (MPFL) injury occurs in more than 95% of lateral patellar dislocations. Most of these injuries result in subsequent lateral patellar instability. Therefore, MPFL reconstruction (MPFLR) is often necessary. The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC), the Knee injury and Osteoarthritis Outcome Score (KOOS) and retear rate.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Lateral patellar dislocation with subsequent instability
- Failure of non-operative treatment
Exclusion criteria
- Active inflammation of the knee;
- Previous surgeries on the patellofemoral joint;
- Fractures around the knee
Treatment and study plan
Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
ProcedureMedial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy. Management of any accompanying patellofemoral lesions will be performed as well.
Primary outcomes
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Lateral patella stability - apprehension test
Time frame: At the 12 month of the follow-up.
Apprehension test at 30 degrees of knee flexion
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Lateral patella stability - lateral luxation test
Time frame: At the 12 month of the follow-up.
Lateral luxation test at 30 degrees of knee flexion
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Lateral patella stability - apprehension test
Time frame: At the 24 month of the follow-up.
Apprehension test at 30 degrees of knee flexion
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Lateral patella stability - lateral luxation test
Time frame: At the 24 month of the follow-up.
Lateral luxation test at 30 degrees of knee flexion
Secondary outcomes
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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
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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
-
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time frame: At the 12 month of the follow-up.
Min of 0 max of 100 points, higher scores mean a better outcome
-
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time frame: At the 24 month of the follow-up.
Min of 0 max of 100 points, higher scores mean a better outcome
-
ROM
Time frame: At the 12 month of the follow-up.
Knee range of motion assessed by the means of goniometer.
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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.
Sponsors and collaborators
Lead sponsor
Artromedical Konrad Malinowski Clinic
Other
Registry information
Official study title
Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
Important dates
- Study start
- 2022
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- May 22, 2023
- Registry last updated
- May 22, 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.