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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05128864
Other study ID # HTO_fulkerson
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2020
Est. completion date May 30, 2022

Study information

Verified date November 2021
Source Centre of Postgraduate Medical Education
Contact Rafal Kaminski, MD PhD
Phone +48227794031
Email kaminski@spskgruca.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare Hight Tibial Osteotomy with or without Fulkerson Osteotomy performed on patients with early stages of Osteoarthritis with patellofemoral joint disorders. The purpose of this study is evaluate which type of osteotomy provides better clinical, radiological and laboratory outcomes.


Description:

Progression of knee cartilage degenerative changes leads to necessary total knee arthroplasty in future, which is the most popular procedure for treating OA. HTO applied at early stages of osteoarthritis allow slow down cartilage degeneration process, but the choice of performed surgery depends on surgeons personal assessment. Patellofemoral Pain Syndrome often occurs with knee arthritis. Antero-medialisation of tibial tubercle is frequent procedures for patella maltracking. So far, both, HTO and Fulkerson osteotomy was performed separately, even if patient have symptoms from patellofemoral joint and OA. The investigators believe that simultaneously surgery of HTO and fulkerson Osteotomy provides better outcomes and significantly slow down knee degeneration.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date May 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination - Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests Exclusion Criteria: - no informed consent to participate in the study - age under 18 years or above 65 - multi ligament injury or single plane knee instability - another musculoskeletal disorders in lower limb - lower limb deformity requiring axis correction below 4o or above 12.5o - joints inflammatory diseases - ASA score > II

Study Design


Intervention

Procedure:
High Tibial Osteotomy
Surgery procedure - High Tibial Osteotomy

Locations

Country Name City State
Poland Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital Otwock Mazowieckie

Sponsors (1)

Lead Sponsor Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biomechanics MRI Patellofemoral Joints Biomechanics improvement measured 1 year
Primary Biomechanics MRI Patellofemoral Joints Biomechanics improvement measured 2 years
Primary Biomechanics X-ray Patellofemoral Joints Biomechanics improvement measured 12 weeks
Primary Biomechanics X-ray Patellofemoral Joints Biomechanics improvement measured 6 months
Primary Biomechanics X-ray Patellofemoral Joints Biomechanics improvement measured 12 months
Primary Biomechanics X-ray Patellofemoral Joints Biomechanics improvement measured 24 months
Secondary KOOS Knee Injury and Osteoarthritis Outcome Score 12 weeks
Secondary KOOS Knee Injury and Osteoarthritis Outcome Score 6 months
Secondary KOOS Knee Injury and Osteoarthritis Outcome Score 12 months
Secondary KOOS Knee Injury and Osteoarthritis Outcome Score 24 months
Secondary IKDC International Knee Documentation Committee 12 weeks
Secondary IKDC International Knee Documentation Committee 6 months
Secondary IKDC International Knee Documentation Committee 12 months,
Secondary IKDC International Knee Documentation Committee 24 months
Secondary Tegner Lysholm Tegner Lysholm Knee Scoring Scale 12 weeks,
Secondary Tegner Lysholm Tegner Lysholm Knee Scoring Scale 6 months
Secondary Tegner Lysholm Tegner Lysholm Knee Scoring Scale 12 months
Secondary Tegner Lysholm Tegner Lysholm Knee Scoring Scale 24 months
Secondary SF-36 The Short Form (36) Health Survey 12 weeks
Secondary SF-36 The Short Form (36) Health Survey 6 months
Secondary SF-36 The Short Form (36) Health Survey 12 months
Secondary SF-36 The Short Form (36) Health Survey 24 months
Secondary VAS Pain Visual Analog Scale 12 week
Secondary VAS Pain Visual Analog Scale 6 months
Secondary VAS Pain Visual Analog Scale 12 months
Secondary VAS Pain Visual Analog Scale 24 months
Secondary Blood test CRP, IL-6, CTx 2nd day
Secondary Blood test CRP, IL-6, CTx 6 weeks
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