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High Tibial Osteotomy With/Without Arthroscopy.

NCT ID: NCT05128851

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

90 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 arthroscopically repair intra-articular knee lesions in patients with early stages of Osteoarthritis.The purpose of this study is evaluate if addition of arthroscopy to HTO provides better clinical, radiological and laboratory outcomes.

Detailed Description

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Intraarticular knee lesions are often in patients with early stages of osteoarthritis. The most frequent findings are degenerative meniscus/meniscal tears and cartilage degeneration. Degenerative meniscal lesions or meniscal tears are often incidental findings without any complains from patients. In the current literature there is no evidence for good clinical outcomes after arthroscopically treatment degenerative meniscus. Cartilage injuries are common in osteoarthritic knee and depending on grading of chondromalacia are usually treated by microfractures. By this time the choice of performed surgery depends on surgeons personal assessment. The investigators believe that concomitant intraarticular procedures added to HTO will provide better clinical outcomes.

Conditions

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Osteoarthritis, Knee Meniscus; Degeneration

Keywords

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HTO Degenerative Meniscus Osteoarthritis Microfracture

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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High Tibial Osteotomy and arthroscopy

High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions.

Group Type ACTIVE_COMPARATOR

HTO

Intervention Type PROCEDURE

Hight Tibial Osteotomy

Arthroscopy treatment

Intervention Type PROCEDURE

Arthroscopy treatment

High Tibial Osteotomy

Descending High Tibial Osteotomy with arthroscopy without treatment of intraarticular lesions.

Group Type SHAM_COMPARATOR

HTO

Intervention Type PROCEDURE

Hight Tibial Osteotomy

High Tibial Osteotomy, arthroscopy and microfractures

High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions and microfracture.

Group Type ACTIVE_COMPARATOR

HTO

Intervention Type PROCEDURE

Hight Tibial Osteotomy

Arthroscopy treatment

Intervention Type PROCEDURE

Arthroscopy treatment

Micro fractures

Intervention Type PROCEDURE

Micro fractures

Interventions

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HTO

Hight Tibial Osteotomy

Intervention Type PROCEDURE

Arthroscopy treatment

Arthroscopy treatment

Intervention Type PROCEDURE

Micro fractures

Micro fractures

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination
* Intraarticular lesions in MRI
* 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
* multilligament 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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Rafał Kamiński

Role: PRINCIPAL_INVESTIGATOR

PCME, Otwock, Poland

Locations

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Department of Orthopaedics and Traumatology, Centre of Postgraduate 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

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_artro

Identifier Type: -

Identifier Source: org_study_id