Prediction of Outcomes Following Total Knee Replacement | NCT01370421

Studies
Prediction of Outcomes Following Total Knee Replacement

NCT01370421

Sponsor

Brigham and Women's Hospital

Status

Completed

Last Update Posted

Mar 2, 2022Actual

Enrollment

248Actual

Phase

Not provided

Conditions

Osteoarthritis

Interventions

Not provided

Countries

United States

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

Feb 2022

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

Apr 2011Actual

Primary Completion Date

Mar 2019Actual

Completion Date

Mar 2019Actual

First Submitted Date

Jun 2, 2011

First Submission Date that Met QC Criteria

Jun 8, 2011

First Posted Date

Jun 10, 2011Estimated

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

Feb 13, 2022

Last Update Posted Date

Mar 2, 2022Actual

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

This is an observational study (not a treatment study) of pain and physical functioning after total knee replacement. The study includes 5 visits, 1 before surgery and 4 after surgery. You may be eligible if you are 50 or older,will soon be undergoing knee replacement surgery, do not have a serious heart condition or certain other medical conditions, and are not taking certain types of medications. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold.

Detailed Description

This is an observational study (not a treatment study) of pain and physical functioning after total knee replacement. The study includes 5 visits, 1 before surgery and 4 after surgery. The last visit will be about 1 year after surgery. You may be eligible if you are 50 or older, will soon be undergoing knee replacement surgery, do not have a serious heart condition or certain other medical conditions, and are not taking certain types of medications. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

248Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Knee OA patients undergoing Total Knee Arthroplasty (TKA)		Participants will be 45 years or older, diagnosed with Osteoarthritis of the knee and be scheduled for a unilateral total knee replacement surgery.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brief Pain Inventory (BPI)	A widely-used measure of pain severity and pain interference. Pain severity and pain interference scores range from 0-10 (0= no pain / no pain interference and 10= severe pain / pain interference).	6 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	A widely-used, OA-specific measure of pain, function, and stiffness. WOMAC Pain scores range from 0-50, with 0= no pain and 50= severe pain.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 50 or older
Meet the American College of Rheumatology criteria for knee osteoarthritis
Scheduled to undergo total knee arthroplasty
Facility with the English language that is adequate to complete study procedures

Exclusion Criteria:

Cognitive impairment preventing completion of study assessment procedures
Myocardial infarction within the past 12 months
Severe raynaud's or severe neuropathy
Active vasculitis or severe peripheral vascular disease
Current infection
Use of oral steroids
Recent history of substance abuse or dependence
Confirmed diagnosis of periodic limb movement disorder or restless legs syndrome
Systemic inflammatory or autoimmune disorders such as rheumatoid arthritis, lupus, etc.
Known anemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Potential participants for this study will be recruited via flyers posted in hospital clinics, on electronic announcement boards and various other media mediums. Potential subjects will be informed about the study purpose and procedures when they call, and interested subjects will then go through a telephone screening.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert R Edwards, PhD	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Chestnut Hill	Massachusetts	02467	United States

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

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Browse Branches

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