Evaluation of a Distraction-rotation Knee Unloader Brace... | NCT01884883

Studies
Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.

NCT01884883

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Jun 24, 2013Estimated

Enrollment

21Actual

Phase

Not Applicable

Conditions

Knee Osteoarthritis

Interventions

PROTEOR Internal unicompartmental knee brace

Countries

France

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

Jun 2013

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

May 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Not provided

First Submitted Date

Jun 18, 2013

First Submission Date that Met QC Criteria

Jun 21, 2013

First Posted Date

Jun 24, 2013Estimated

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

Jun 21, 2013

Last Update Posted Date

Jun 24, 2013Estimated

Description Module

Brief Summary

The aim of this study is to confirm the biomechanical effects and evaluate functional benefits of a new knee brace combining valgus inducing effect on medial compartment and leg external rotation during the stance phase in patients with symptomatic medial knee osteoarthritis.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Internal unicompartmental knee brace	Other		Device: PROTEOR Internal unicompartmental knee brace

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PROTEOR Internal unicompartmental knee brace	Device		Internal unicompartmental knee brace	trademark : " PROTEOR " : code name 2H-200

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score on visual analogic scale	Pain was self-evaluated by patient on visual analogic scale (VAS: 0-100, 0 = no pain at all; 100 = worst pain appendix 1). Such pain is widely used and validated in the literature for the evaluation of knee osteoarthritis treatment outcome.	Baseline
Pain score on visual analogic scale	Pain was self-evaluated by patient on visual analogic scale (VAS: 0-100, 0 = no pain at all; 100 = worst pain appendix 1). Such pain is widely used and validated in the literature for the evaluation of knee osteoarthritis treatment outcome.	Baseline + 5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the functional capacities: KOOS questionnaire.		baseline
Evaluation of the functional capacities: KOOS questionnaire.		baseline + 5 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient understanding simple order and able to give written consent.
Man or woman with age between 40 et 75 years
Unilateral medial symptomatic knee osteoarthritis, defined using the American College of Rheumatology classification
Radiologic grade II, III ou IV (Kellgren et Lawrence (KL) classification)
Medial knee compartment (Medial K&L g rade higher than lateral K&L grade
Knee pain > 40/100 on visual analog scale and <30/100 for the other
No change in medical treatment for at least 3 months.
Latest radiographic image < 12 months before inclusion

Exclusion Criteria:

Patient without healthcare insurance.
Inflammatory knee arthritis,
Indication of knee surgery
Pregnancy, breastfeeding
Associate neurologic or orthopaedic affection that interferes with gait analysis
Rapidly destructive arthritis.
Alzheimer's disease, Parkinson's disease, motor neuronal disorders
Patient under guardianship or tutelage

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 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
Jean-Francis Maillefert	CHU Dijon - Department of Rheumatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Dijon		Dijon		21079	France

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided