AzTrials
AzTrials

Osteoarthrosis of KneeOHTONCT03448796

Opening Wedge High Tibial Osteotomy

A study testing HTO and Supervised physiotherapeutic program in people with Osteoarthrosis of Knee and Osteoarthritis, Knee, run by Kuopio University Hospital at 1 site in Finland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 to 55 years
Conditions the study is for
Osteoarthrosis of Knee, Osteoarthritis, Knee
What is being tested?
HTO and Supervised physiotherapeutic program
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteFinland
Study dates
1 May 2018to 10 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • University Hospital of Kuopio

    Kuopio

Other trials in Finland

About this study

Official title: High Tibial Opening Wedge Osteotomy and Conservative Treatment in Medial Knee Osteoarthritis - A Randomised Controlled Trial

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.

Read the detailed description

90 Symptomatic patients with mild to moderate medial knee osteoarthrosis are randomized to two groups:

Group 1 (HTO-group) receive an diagnostic arthroscopy with high tibial opening wedge osteotomy (Tomofix-plate). Postoperatively a supervised physiotherapeutic rehabilitation program is started.

Group 2 (FT-group) receive the same supervised physiotherapeutic rehabilitation program without the HTO or arthroscopy.

Primary outcome measure is composite score of Knee injury and Osteoarthritis Outcome Score (KOOS5).

Secondary outcome measures are pain (VAS), KOOS subscales, objective physical performance measurements, progression of osteoarthrosis (X-ray, MRI), change of mechanical axis, complications, treatment costs, rate of reoperation, revision to total knee arthroplasty (TKA), biological markers of arthrosis progression, 15D (quality of life assessment), QALY (Quality-Adjusted Life-Year), Work Productivity and Activity Impairment Questionnaire, Work Productivity and Activity Impairment Questionnaire, sum of governmental benefits received.

Outcomes will be measured at 24, 60 and 120 months after the intervention.

Being tested
HTO, Supervised physiotherapeutic program
Keywords
High tibial osteotomy, Osteoarthrosis, Tomofix, Randomized controlled trial
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HTOProcedure or surgery

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

  • Supervised physiotherapeutic programOther

    Group that receives only supervised physiotherapy as treatment.

Study groups in NCT03448796
Study groupRoleWhat they receive
HTO-groupActive comparatorGroup receives opening wedge high tibial osteotomy with Tomofix -plate. Operative intervention is followed by supervised physiotherapeutic rehabilitation.
Receives: Procedure: HTO; Other: Supervised physiotherapeutic program
FT -groupActive comparatorGroup receives only supervised physiotherapeutic rehabilitation.
Receives: Other: Supervised physiotherapeutic program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of KOOS5

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

    Measured: 24, 60, 120 months

Secondary outcomes (17)

  1. Change of pain measured in numeric rated scale (NRS)

    Amount of subjective (knee) pain

    Measured: 24, 60, 120 months

  2. Change of KOOS subscales

    Individual subscales of Knee injury and Osteoarthritis Outcome Scores

    Measured: 24, 60, 120 months

  3. Change in results of 40 meter fast paced walk test

    A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft)

    Measured: 24, 60, 120 months

  4. Change in results of stair climb test

    The time (in seconds) it takes to ascend and descend a flight of stairs

    Measured: 24, 60, 120 months

  5. Change in results of timed up and go test

    Time (seconds) taken to rise from a chair, walk 3 m, turn, walk back to the chair, then sit down wearing regular footwear and using a walking aid if required.

    Measured: 24, 60, 120 months

  6. Radiological progression of arthrosis

    x-ray, MRI

    Measured: 24, 60, 120 months

  7. Change in mechanical axis of lower limb

    As measured from whole leg standing radiograph

    Measured: 12, 24, 60, 120 months

  8. Incidence of complications

    eg infection, non-union, thromboembolic complications etc.

    Measured: Up to 120 months

  9. Total costs of treatment

    Including the cost of hospital treatment, physiotherapy, cost of medication, cost of sick leave

    Measured: Up to 120 months

  10. Incidence of reoperation

    Amount of reoperations needed

    Measured: Up to 120 months

  11. Hyaluronic acid (HA) concentration

    At 24, 60 and 120 month follow-up blood and synovial fluid samples are analyzed for HA concentration.

    This will be measured with antibody-ELISA at mg/g from 10µl of fluid. The same measurement will be conducted on blood serum.

    Measured: 24, 60, 120 months

  12. Fatty acid (FA) profiling

    At 24, 60 and 120 month follow-up blood and synovial fluid samples are analyzed for fatty acid (FA) profiling. FA will be analyzed from 75 µl of synovial fluid and 200 µl of blood serum with gas chromatography as mol-%.

    Measured: 24, 60, 120 months

  13. Synovial fluid composition

    At 24, 60 and 120 month follow-up synovial fluid samples are analyzed for composition.

    Synovial fluid composition will be assessed visually with confocal microscopy with a HA-biding fluorescent probe and Nile red probe that show both HA particles and the association of these particles on extracellular vesicles to assess the significance of vesicle-mediated HA secretion into synovial fluid.

    Measured: 24, 60, 120 months

  14. General variables reflecting inflammatory status

    At 24, 60 and 120 month follow-up blood and blood serum samples are analyzed for general variables reflecting inflammatory status (leucocytes, C-reactive protein, IL-6).

    Measured: 24, 60, 120 months

  15. 15D -quality of life assessement

    The change of health-related quality of life (HRQoL) instrument

    Measured: 24, 60, 120 months

  16. Work Productivity and Activity Impairment Questionnaire (WPAI)

    The change of WPAI

    Measured: 24, 60, 120 months

  17. Amount of national benefits received

    The amount of benefits are gathered from:

    1. The hospital discharge register (maintained by National Institute for Health and Welfare)
    2. National benefits paid by The Social Insurance Institution of Finland
    3. Pension decision made by Finnish Centre for Pensions

    Measured: Up to 120 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study start1 May 2018
  3. Primary completion10 May 2023
  4. Study completion10 May 2023

Why it stopped: Problems with recruiting patients.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized controlled trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448796
Sponsor's protocol ID
KUH5203099
Acronym
OHTO
Status last verified
Apr 2021
First submitted
2 Mar 2017
Last updated
27 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing HTO and Supervised physiotherapeutic program in people with Osteoarthrosis of Knee and Osteoarthritis, Knee, run by Kuopio University Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Problems with recruiting patients.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of KOOS5 (time frame: 24, 60, 120 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03448796.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in