NCT00426907

Brief Summary

In this project we want investigate the clinical results after different rehabilitation regimens(Limited or unlimited weightbearing after surgery) in Open-wedge High Tibial Osteotomies. The hypothesis is that unlimited weightbearing is beneficial for the healing and rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2007

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

7.7 years

First QC Date

January 23, 2007

Last Update Submit

April 9, 2015

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, KneeOsteotomyHealingRehabilitationRoentgen Stereometric Analysis

Outcome Measures

Primary Outcomes (1)

  • Migration in mm measured with RSA (Roentgen Stereometric Analysis):

    Postoperative, at 3 month, 1 and 2 years.

Secondary Outcomes (3)

  • Clinical scores including range of Movement and muscular status at 6 weeks, 3 month, 1 and 2 years postoperative.

    Postoperative, at 3 month, 1 and 2 years.

  • Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative.

    Postoperative, at 3 month, 1 and 2 years.

  • Bone Mineral Density (DEXA-scan) pre-op., Post.-op, at 6 weeks, 3 months and 1 and 2 years postop.

    Postoperative, at 3 month, 1 and 2 years.

Study Arms (2)

1

EXPERIMENTAL

Full postoperative weightbearing

Procedure: Unlimited postoperative weightbearing

2

ACTIVE COMPARATOR

Partial weightbearing 6 weeks postoperative

Procedure: Unlimited postoperative weightbearing

Interventions

Unlimited postoperative weightbearingPROCEDURE

Unlimited postoperative weightbearing

12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2
  • Varus deformity

You may not qualify if:

  • Prednisolone treatment.
  • NSAID treatment.
  • BMI \> or = 35.
  • Previous surgery in lateral knee compartment.
  • Secondary Arthrosis following fracture(s) of the tibial condyle(s).
  • Lack of informed consent.
  • Correction \>12,5 mm
  • Peroperative displaced fracture of lateral bony hinge.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital

Farsø, Northern Jutland, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Thomas Lind-Hansen, MD

    Orthopaedic Division, Northern Denmark Region

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 25, 2007

Study Start

January 1, 2007

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

DK(1)