NCT03448796

Brief Summary

A prospective, randomised controlled trial where clinical and radiological outcome of high tibial opening wedge osteotomy with physiotherapy is compared to physiotherapy alone while treating symptomatic medial knee osteoarthrosis.

Trial Health

57
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Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2017

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

October 27, 2023

Status Verified

April 1, 2021

Enrollment Period

5 years

First QC Date

March 2, 2017

Last Update Submit

October 25, 2023

Conditions

Osteoarthrosis of KneeOsteoarthritis, Knee

Keywords

High tibial osteotomyOsteoarthrosisTomofixRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Change of KOOS5

    The change of Composite score of Knee injury and Osteoarthritis Outcome Score (KOOS) subscales

    24, 60, 120 months

Secondary Outcomes (17)

  • Change of pain measured in numeric rated scale (NRS)

    24, 60, 120 months

  • Change of KOOS subscales

    24, 60, 120 months

  • Change in results of 40 meter fast paced walk test

    24, 60, 120 months

  • Change in results of stair climb test

    24, 60, 120 months

  • Change in results of timed up and go test

    24, 60, 120 months

  • +12 more secondary outcomes

Study Arms (2)

HTO-group

ACTIVE COMPARATOR

Group receives opening wedge high tibial osteotomy with Tomofix -plate. Operative intervention is followed by supervised physiotherapeutic rehabilitation.

Procedure: HTOOther: Supervised physiotherapeutic program

FT -group

ACTIVE COMPARATOR

Group receives only supervised physiotherapeutic rehabilitation.

Other: Supervised physiotherapeutic program

Interventions

HTOPROCEDURE

Group that receives high tibial osteotomy combined with supervised physiotherapy as treatment.

HTO-group
Supervised physiotherapeutic programOTHER

Group that receives only supervised physiotherapy as treatment.

FT -groupHTO-group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pain: Subjective pain in the knee most of the month for at least one month during past 12 months.
  • Knee range of motion (ROM) at least 5-120 degrees
  • X-ray: medial joint space Altman \> 1. Lateral joint space Altman \< 2.
  • Mechanical axis \> 3 degrees varus alignment.
  • Medial proximal tibial angle (MPTA) \< 90 degrees
  • age 25-55.
  • Written consent, accepts both treatment arms.

You may not qualify if:

  • Pain is caused by something else than medial knee osteoarthrosis
  • deficient ROM (flexion contracture \> 10 degrees, flexion \< 110 degrees)
  • significant ligament instability
  • post traumatic OA
  • clinically relevant neurological disease (e.g. Alzheimer´s disease)
  • clinically relevant metabolical disease (e.g. Diabetes)
  • alcohol/drug abuse
  • infectious/inflammatory joint disease
  • previous knee area osteotomy or lower limb arthroplasty
  • smoking (\> 0 cigarette per day)
  • obesity (BMI \> 33)
  • pregnancy or hope of pregnancy in the following two years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Kuopio

Kuopio, Finland

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jussi Jalkanen, M.D.

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The clinical assessors are blinded when applicable.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

February 28, 2018

Study Start

May 1, 2018

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

October 27, 2023

Record last verified: 2021-04

Locations

FI(1)