High Tibial Osteotomy With/Without Arthroscopy.

Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Arthroscopic Treatment of Knee Intraarticular Lesions.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05128851

Enrollment

Registered

2021-11-22

Start date

2020-07-15

Completion date

2022-05-30

Last updated

2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniscus; Degeneration, Osteoarthritis, Knee

Keywords

HTO, Degenerative Meniscus, Osteoarthritis, Microfracture

Brief summary

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

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.

Interventions

PROCEDUREHTO

Hight Tibial Osteotomy

PROCEDUREArthroscopy treatment

Arthroscopy treatment

PROCEDUREMicro fractures

Micro fractures

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
KOOS	12 months	Knee Injury and Osteoarthritis Outcome Score
IKDC	12 months	International Knee Documentation Committee - Subjective Knee Evaluation Form
VAS	12 months	Visual Analog Scale
Blood test	2 day	no inflammatory reaction - CRP, Il-6, CTx

Secondary

Measure	Time frame	Description
Kinematic MRI with [chondrogram]	2 day,	Meniscus healing, cartilage quality
X-ray - Baldini projection	2 day	Patellofemoral joint measurements

Countries

Poland

Contacts

Primary ContactRafał Kamiński

rkaminski@spskgruca.pl+48227794031

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026