Opening Wedge High Tibial Osteotomy

Osteoarthritis, Knee Clinical Trial

— OHTO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03448796
• Other study ID #: KUH5203099
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: May 10, 2023

Study information

• Verified date: April 2021
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 10, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthrosis of Knee

Intervention

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.

Locations

Country	Name	City	State
Finland	University Hospital of Kuopio	Kuopio

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	Central Finland Hospital District

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of KOOS5	The change of Composite score of Knee injury and Osteoarthritis Outcome Score (KOOS) subscales	24, 60, 120 months
Secondary	Change of pain measured in numeric rated scale (NRS)	Amount of subjective (knee) pain	24, 60, 120 months
Secondary	Change of KOOS subscales	Individual subscales of Knee injury and Osteoarthritis Outcome Scores	24, 60, 120 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Radiological progression of arthrosis	x-ray, MRI	24, 60, 120 months
Secondary	Change in mechanical axis of lower limb	As measured from whole leg standing radiograph	12, 24, 60, 120 months
Secondary	Incidence of complications	eg infection, non-union, thromboembolic complications etc.	Up to 120 months
Secondary	Total costs of treatment	Including the cost of hospital treatment, physiotherapy, cost of medication, cost of sick leave	Up to 120 months
Secondary	Incidence of reoperation	Amount of reoperations needed	Up to 120 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	15D -quality of life assessement	The change of health-related quality of life (HRQoL) instrument	24, 60, 120 months
Secondary	Work Productivity and Activity Impairment Questionnaire (WPAI)	The change of WPAI	24, 60, 120 months
Secondary	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