Weightbearing After High Tibial Osteotomy | NCT00426907

Studies
Weightbearing After High Tibial Osteotomy

NCT00426907

Sponsor

Northern Orthopaedic Division, Denmark

Status

Completed

Last Update Posted

Apr 10, 2015Estimated

Enrollment

20Actual

Phase

Phase 4

Conditions

Osteoarthritis, Knee

Interventions

Unlimited postoperative weightbearing

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Jan 23, 2007

First Submission Date that Met QC Criteria

Jan 23, 2007

First Posted Date

Jan 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2015

Last Update Posted Date

Apr 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high tibial osteotomy is a good choice of treatment for the young and active patient.

However it leaves an open gap which has to be filled with a bone substitute and requires stable fixation.

Different rehabilitation-regimens are described, many advocating a period of partial weight-bearing for a period after surgery.

Results from biomechanical studies suggest that immediate full weight-bearing is safe, enabling earlier mobilisation without compromising safe solid healing.

The aim of the present study is to evaluate whether there is any difference in clinical outcome, correction, stability and healing in open-wedge osteotomies (osteosynthesis with the Dynafix® system (EBI)) after 2 different rehabilitation regimens: Limited weight-bearing (20 kg) for 6 weeks, and unrestricted weight-bearing.

The investigation is performed as a randomised prospective clinical trial including 20 patients with a planned 2 years follow-up period.

Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and Lysholm score.

Routine standing x-rays is performed. Stability of the osteotomy is assessed with Roentgen Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional measuring of eventual loss of correction.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Full postoperative weightbearing	Procedure: Unlimited postoperative weightbearing
2	Active Comparator	Partial weightbearing 6 weeks postoperative	Procedure: Unlimited postoperative weightbearing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Unlimited postoperative weightbearing	Procedure	Unlimited postoperative weightbearing	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Migration in mm measured with RSA (Roentgen Stereometric Analysis):		Postoperative, at 3 month, 1 and 2 years.

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Lind-Hansen, MD	Orthopaedic Division, Northern Denmark Region	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital		Farsø	Northern Jutland		Denmark

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

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