NCT03448796

Opening Wedge High Tibial Osteotomy

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Kuopio University Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthrosis of Knee
• Osteoarthritis, Knee

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-01
• Primary completion: 2023-05-10
• Completion: 2023-05-10
• First posted: 2018-02-28
• Last updated: 2023-10-27

Locations

1 site across 1 country: Finland