High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA

Osteoarthritis, Knee Clinical Trial

Official title:

Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Fulkerson Osteotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05128864
• Other study ID #: HTO_fulkerson
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Patellofemoral Disorder

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