Clinical trial NCT03448796: Opening Wedge High Tibial Osteotomy
Official title: High Tibial Opening Wedge Osteotomy and Conservative Treatment in Medial Knee Osteoarthritis - A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthrosis of Knee
Osteoarthritis, Knee
Keywords: High tibial osteotomy
Osteoarthrosis
Tomofix
Randomized controlled trial
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Central Finland Hospital District
First posted: 2018-02-28
Enrollment: 1
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of KOOS5
timeFrame: 24, 60, 120 months
Secondary outcomes:
measure: Change of pain measured in numeric rated scale (NRS)
timeFrame: 24, 60, 120 months
measure: Change of KOOS subscales
timeFrame: 24, 60, 120 months
measure: Change in results of 40 meter fast paced walk test
timeFrame: 24, 60, 120 months
measure: Change in results of stair climb test
timeFrame: 24, 60, 120 months
measure: Change in results of timed up and go test
timeFrame: 24, 60, 120 months
measure: Radiological progression of arthrosis
timeFrame: 24, 60, 120 months
measure: Change in mechanical axis of lower limb
timeFrame: 12, 24, 60, 120 months
measure: Incidence of complications
timeFrame: Up to 120 months
measure: Total costs of treatment
timeFrame: Up to 120 months
measure: Incidence of reoperation
timeFrame: Up to 120 months
measure: Hyaluronic acid (HA) concentration
timeFrame: 24, 60, 120 months
measure: Fatty acid (FA) profiling
timeFrame: 24, 60, 120 months
measure: Synovial fluid composition
timeFrame: 24, 60, 120 months
measure: General variables reflecting inflammatory status
timeFrame: 24, 60, 120 months
measure: 15D -quality of life assessement
timeFrame: 24, 60, 120 months
measure: Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: 24, 60, 120 months
measure: Amount of national benefits received
timeFrame: Up to 120 months
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University Hospital of Kuopio
Study officials:
affiliation: Kuopio University Hospital
name: Jussi Jalkanen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: