Opening Wedge High Tibial Osteotomy (OHTO)

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis, Knee; Osteoarthrosis of Knee
• Intervention / Treatment: Procedure: HTO; Other: Supervised physiotherapeutic program

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland
    • University Hospital of Kuopio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HTO-group; Group receives opening wedge high tibial osteotomy with Tomofix -plate. Operative intervention is followed by supervised physiotherapeutic rehabilitation.	Procedure: HTO; Group that receives high tibial osteotomy combined with supervised physiotherapy as treatment.; Other: Supervised physiotherapeutic program; Group that receives only supervised physiotherapy as treatment.
Active Comparator: FT -group; Group receives only supervised physiotherapeutic rehabilitation.	Other: Supervised physiotherapeutic program; Group that receives only supervised physiotherapy as treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of KOOS5	The change of Composite score of Knee injury and Osteoarthritis Outcome Score (KOOS) subscales	24, 60, 120 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of pain measured in numeric rated scale (NRS)	Amount of subjective (knee) pain	24, 60, 120 months
Change of KOOS subscales	Individual subscales of Knee injury and Osteoarthritis Outcome Scores	24, 60, 120 months
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)	24, 60, 120 months
Change in results of stair climb test	The time (in seconds) it takes to ascend and descend a flight of stairs	24, 60, 120 months
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.	24, 60, 120 months
Radiological progression of arthrosis	x-ray, MRI	24, 60, 120 months
Change in mechanical axis of lower limb	As measured from whole leg standing radiograph	12, 24, 60, 120 months
Incidence of complications	eg infection, non-union, thromboembolic complications etc.	Up to 120 months
Total costs of treatment	Including the cost of hospital treatment, physiotherapy, cost of medication, cost of sick leave	Up to 120 months
Incidence of reoperation	Amount of reoperations needed	Up to 120 months
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.	24, 60, 120 months
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-%.	24, 60, 120 months
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.	24, 60, 120 months
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).	24, 60, 120 months
15D -quality of life assessement	The change of health-related quality of life (HRQoL) instrument	24, 60, 120 months
Work Productivity and Activity Impairment Questionnaire (WPAI)	The change of WPAI	24, 60, 120 months
Amount of national benefits received	The amount of benefits are gathered from: The hospital discharge register (maintained by National Institute for Health and Welfare); National benefits paid by The Social Insurance Institution of Finland; Pension decision made by Finnish Centre for Pensions	Up to 120 months

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: Central Finland Hospital District
• Investigators: Principal Investigator: Jussi Jalkanen, M.D., Kuopio University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Osteoarthrosis; High tibial osteotomy; Tomofix
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: KUH5203099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No