NCT05128851

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

1.9 years

First QC Date

July 3, 2020

Last Update Submit

November 9, 2021

Conditions

Osteoarthritis, KneeMeniscus; Degeneration

Keywords

HTODegenerative MeniscusOsteoarthritisMicrofracture

Outcome Measures

Primary Outcomes (9)

  • KOOS

    Knee Injury and Osteoarthritis Outcome Score

    12 months

  • KOOS

    Knee Injury and Osteoarthritis Outcome Score

    24 months

  • IKDC

    International Knee Documentation Committee - Subjective Knee Evaluation Form

    12 months

  • IKDC

    International Knee Documentation Committee - Subjective Knee Evaluation Form

    24 months

  • VAS

    Visual Analog Scale

    12 months

  • VAS

    Visual Analog Scale

    24 months

  • Blood test

    no inflammatory reaction - CRP, Il-6, CTx

    2 day

  • Blood test

    no inflammatory reaction - CRP, Il-6, CTx

    6 weeks

  • Blood test

    no inflammatory reaction - CRP, Il-6, CTx

    12 weeks,

Secondary Outcomes (4)

  • Kinematic MRI with [chondrogram]

    2 day,

  • Kinematic MRI with [chondrogram]

    24 months

  • X-ray - Baldini projection

    2 day

  • X-ray - Baldini projection

    24 months

Study Arms (3)

High Tibial Osteotomy and arthroscopy

ACTIVE COMPARATOR

High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions.

Procedure: HTOProcedure: Arthroscopy treatment

High Tibial Osteotomy

SHAM COMPARATOR

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

Procedure: HTO

High Tibial Osteotomy, arthroscopy and microfractures

ACTIVE COMPARATOR

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

Procedure: HTOProcedure: Arthroscopy treatmentProcedure: Micro fractures

Interventions

HTOPROCEDURE

Hight Tibial Osteotomy

High Tibial OsteotomyHigh Tibial Osteotomy and arthroscopyHigh Tibial Osteotomy, arthroscopy and microfractures
Arthroscopy treatmentPROCEDURE

Arthroscopy treatment

High Tibial Osteotomy and arthroscopyHigh Tibial Osteotomy, arthroscopy and microfractures
Micro fracturesPROCEDURE

Micro fractures

High Tibial Osteotomy, arthroscopy and microfractures

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Otwock, Masovian Voivodeship, 05-400, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisFractures, Stress

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesFractures, BoneWounds and Injuries

Study Officials

  • Rafał Kamiński

    PCME, Otwock, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafał Kamiński

CONTACT

+48227794031rkaminski@spskgruca.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Division

Study Record Dates

First Submitted

July 3, 2020

First Posted

November 22, 2021

Study Start

July 15, 2020

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations

PL(1)