MPFLR With Fascia Lata Allograft, Based on Isometry Assessment + Elmslie-Trillat TTO

Not Applicable

Recruiting

• Conditions: Lateral Patellofemoral Dislocation Closed Traumatic; Lateral Patellar Luxation
• Interventions: Procedure: Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.

• Registration Number: NCT05868434
• Lead Sponsor: Artromedical Konrad Malinowski Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-02-25
• Status Verified: 2023-05
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-18
• Last Update Submitted: 2023-05-18
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main arm of the study	Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.	Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy will be performed in these patients.

Primary Outcome Measures

Name	Time	Method
Lateral patella stability - apprehension test	At the 24 month of the follow-up.	Apprehension test at 30 degrees of knee flexion
Lateral patella stability - lateral luxation test	At the 24 month of the follow-up.	Lateral luxation test at 30 degrees of knee flexion

Secondary Outcome Measures

Name	Time	Method
ROM	At the 24 month of the follow-up.	Knee range of motion assessed by the means of goniometer.
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)	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	At the 24 month of the follow-up.	Min of 0 max of 100 points, higher scores mean a better outcome

Trial Locations

Locations (1)

Artromedical Orthopaedic Clinic; 🇵🇱 Bełchatów, Łódzkie, Poland