Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.

Osteoarthritis Clinical Trial

Official title:

Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797003
• Other study ID #: TKN-003
• Status: Completed
• Phase: N/A
• Start date: March 2007
• Est. completion date: January 2017

Study information

• Verified date: October 2022
• Source: Martina Hansen's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for treatment of medial knee osteoarthritis.

Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We will compare functional results and patient satisfaction with repetitive evaluations from preoperatively to 2 years postoperatively.

Description:

Determination of the time course of patient-relevant functional outcome and the time course of Range of Motion (ROM) following HTO. Comparison of the Opening wedge and Closing wedge methods.

Time-dependent improvement in functional outcome following High tibial Osteotomy. Medial opening wedge vs Lateral closing wedge. A two-year prospective randomized study involving 70 patients.

In a prospective randomized study, we plan to include 70 patients aged 30-60 years operated with valgus high tibial osteotomy. 2 groups: 35 opening wedge, and 35 closing wedge osteotomies. Data are collected by independent investigators (physiotherapists) preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. Knee injury and Osteoarthritis Outcome Score (KOOS) and ROM are determined at all follow-ups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Medial osteoarthritis in the knee (x-ray and arthroscopy)

• Pain in medial compartment of the knee

• Correction angle of 5 degrees or more

Exclusion Criteria:

• Former or active infection in the knee

• Rheumatoid arthritis or other similar disease

• Cancer

• Neurological disease

• Kidney disease or metabolic disease

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• High tibial osteotomy

Locations

Country	Name	City	State
Norway	Martina Hansens Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Martina Hansen's Hospital	South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oxford knee score	The change in Oxford score are followed at several time points the first 2 years. Patients will be evaluated with Oxford knee score, 3 months, 6 months, 1 year and 2 years postoperatively.	2 years
Other	Lysholm score	The change in Lysholm score are followed at several time points the first 2 years. Patients will be evaluated with Lysholm, 3 months, 6 months, 1 year and 2 years postoperatively.	2 years postoperatively
Other	UCLA activity scale	The change in UCLA scale are followed at several time points the first 2 years. Patients will be evaluated with UCLA activity scale, 3 months, 6 months, 1 year and 2 years postoperatively.	2 years postoperatively
Other	Tegner Activity Score	The change in Tegner score are followed at several time points the first 2 years. Patients will be evaluated with Tegner score, 3 months, 6 months, 1 year and 2 years postoperatively.	2 years postoperatively
Primary	Kne injury and Osteoarthritis Outcome Score (KOOS)	The change in KOOS score are followed at several time points the first 2 years. Patients will be evaluated with KOOS, 3 months, 6 months, 1 year and 2 years postoperatively.	2 years postoperataively
Secondary	Range of motion (ROM)	The change in ROM are followed at several time points the first 2 years. ROM will be measured 3 months, 6 months, 1 year and 2 years postoperatively.	2 years postoperatively