NCT01797003

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

9.8 years

First QC Date

February 20, 2013

Last Update Submit

October 14, 2022

Conditions

Osteoarthritis

Keywords

osteoarthritisosteotomyclosingopeningwedgeknetibia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Range of motion (ROM)

    2 years postoperatively

Other Outcomes (4)

  • Oxford knee score

    2 years

  • Lysholm score

    2 years postoperatively

  • UCLA activity scale

    2 years postoperatively

  • +1 more other outcomes

Study Arms (2)

Opening wedge HTO

ACTIVE COMPARATOR

Opening wedge high tibial osteotomy using Puddu plate

Other: High tibial osteotomy

Closing wedge HTO

ACTIVE COMPARATOR

Closing wedge high tibial osteotomy using cramp fixation

Other: High tibial osteotomy

Interventions

High tibial osteotomyOTHER
Closing wedge HTOOpening wedge HTO

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Medial osteoarthritis in the knee (x-ray and arthroscopy)
  • Pain in medial compartment of the knee
  • Correction angle of 5 degrees or more

You may not qualify if:

  • Former or active infection in the knee
  • Rheumatoid arthritis or other similar disease
  • Cancer
  • Neurological disease
  • Kidney disease or metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martina Hansens Hospital

Oslo, 0756, Norway

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Tor Kjetil Nerhus, MD

    Consultant orthopaedic surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Orthopaedic surgeon

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 22, 2013

Study Start

March 1, 2007

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 18, 2022

Record last verified: 2022-10

Locations

NO(1)