High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Patellofemoral Disorder
• Intervention / Treatment: Procedure: High Tibial Osteotomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rafał Kamiński, MD PhD; Phone Number: 469 +48227794031; Email: kaminski@spskgruca.pl

Study Locations

• Poland
  • Mazowieckie
    • Otwock, Mazowieckie, Poland, 05-400
      • Recruiting
      • Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital
      • Contact: Rafal Kaminski, MD PhD; Phone Number: 431 +48227794031; Email: rkaminski@spskgruca.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: HTO and Fulkerson; High Tibial Osteotomy with Antero-medialisation of Tibial Tubercle	Procedure: High Tibial Osteotomy; Surgery procedure - High Tibial Osteotomy
SHAM_COMPARATOR: HTO; Descending Hight Tibial Osteotomy	Procedure: High Tibial Osteotomy; Surgery procedure - High Tibial Osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomechanics MRI	Patellofemoral Joints Biomechanics improvement measured	1 year
Biomechanics MRI	Patellofemoral Joints Biomechanics improvement measured	2 years
Biomechanics X-ray	Patellofemoral Joints Biomechanics improvement measured	12 weeks
Biomechanics X-ray	Patellofemoral Joints Biomechanics improvement measured	6 months
Biomechanics X-ray	Patellofemoral Joints Biomechanics improvement measured	12 months
Biomechanics X-ray	Patellofemoral Joints Biomechanics improvement measured	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS	Knee Injury and Osteoarthritis Outcome Score	12 weeks
KOOS	Knee Injury and Osteoarthritis Outcome Score	6 months
KOOS	Knee Injury and Osteoarthritis Outcome Score	12 months
KOOS	Knee Injury and Osteoarthritis Outcome Score	24 months
IKDC	International Knee Documentation Committee	12 weeks
IKDC	International Knee Documentation Committee	6 months
IKDC	International Knee Documentation Committee	12 months,
IKDC	International Knee Documentation Committee	24 months
Tegner Lysholm	Tegner Lysholm Knee Scoring Scale	12 weeks,
Tegner Lysholm	Tegner Lysholm Knee Scoring Scale	6 months
Tegner Lysholm	Tegner Lysholm Knee Scoring Scale	12 months
Tegner Lysholm	Tegner Lysholm Knee Scoring Scale	24 months
SF-36	The Short Form (36) Health Survey	12 weeks
SF-36	The Short Form (36) Health Survey	6 months
SF-36	The Short Form (36) Health Survey	12 months
SF-36	The Short Form (36) Health Survey	24 months
VAS	Pain Visual Analog Scale	12 week
VAS	Pain Visual Analog Scale	6 months
VAS	Pain Visual Analog Scale	12 months
VAS	Pain Visual Analog Scale	24 months
Blood test	CRP, IL-6, CTx	2nd day
Blood test	CRP, IL-6, CTx	6 weeks

Collaborators and Investigators

• Sponsor: Centre of Postgraduate Medical Education

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2020
• Primary Completion (ANTICIPATED): May 30, 2022
• Study Completion (ANTICIPATED): May 30, 2022

Study Registration Dates

• First Submitted: July 18, 2020
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (ACTUAL): November 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Osteoarthritis; HTO; Fulkerson
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HTO_fulkerson

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No