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High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA

NCT ID: NCT05128864

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2022-05-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoarthritis, Knee Patellofemoral Disorder

Keywords

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HTO Fulkerson Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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HTO and Fulkerson

High Tibial Osteotomy with Antero-medialisation of Tibial Tubercle

Group Type ACTIVE_COMPARATOR

High Tibial Osteotomy

Intervention Type PROCEDURE

Surgery procedure - High Tibial Osteotomy

HTO

Descending Hight Tibial Osteotomy

Group Type SHAM_COMPARATOR

High Tibial Osteotomy

Intervention Type PROCEDURE

Surgery procedure - High Tibial Osteotomy

Interventions

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High Tibial Osteotomy

Surgery procedure - High Tibial Osteotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre of Postgraduate Medical Education

OTHER

Sponsor Role lead

Responsible Party

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Rafał Kamiński

Chair of Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafal Kaminski

Role: PRINCIPAL_INVESTIGATOR

PCME, Otwock, Poland

Locations

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Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital

Otwock, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Rafał Kamiński, MD PhD

Role: CONTACT

Phone: +48227794031

Email: [email protected]

Facility Contacts

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Rafal Kaminski, MD PhD

Role: primary

Stanislaw Pomianowski, MD PhD Prof

Role: backup

Other Identifiers

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HTO_fulkerson

Identifier Type: -

Identifier Source: org_study_id