Optimal Management of Extreme Obesity and Severe Knee Ost... | NCT05120492

Studies
Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial

NCT05120492

Sponsor

Nova Scotia Health Authority

Status

Recruiting

Last Update Posted

Aug 21, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Knee Osteoarthritis
Morbid Obesity

Interventions

bariatric surgery followed by total knee replacement

Countries

Canada

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2022Actual

Primary Completion Date

Jul 2027Estimated

Completion Date

Jul 2027Estimated

First Submitted Date

Nov 3, 2021

First Submission Date that Met QC Criteria

Nov 3, 2021

First Posted Date

Nov 15, 2021Actual

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

Aug 19, 2024

Last Update Posted Date

Aug 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery

Detailed Description

RCT involving patients who have severe knee osteoarthritis and have a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 45 to 60 and are randomly assigned to receive dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (control arm) or sleeve gastrectomy with dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (treatment arm).

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical weight loss	Experimental	sleeve gastrectomy + dietary and lifestyle counseling prior to total knee replacement	Procedure: bariatric surgery followed by total knee replacement
Standard of Care	No Intervention	dietary and lifestyle counseling prior to total knee replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bariatric surgery followed by total knee replacement	Procedure	The only intervention is the randomization of the priority of the 2 procedures.	Surgical weight loss

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain, mobility and quality of Life	Knee Injury and Osteoarthritis Outcome Score (KOOS4)	1 year

Secondary Outcomes

Measure	Description	Time Frame
EuroQol Group 5-Dimension Self Report Questionnaire (EQ-5D)	assessing quality of life.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

severe knee osteoarthritis body-mass index of 45 to 60

Exclusion Criteria:

previous total replacement of the same knee, a need for bilateral total knee replacement, and knee pain during the previous week that the patient rated at higher than 60 mm on a 100-mm visual-analogue scale. Also,prior bariatric or complex foregut surgery, significant cardiovascular, pulmonary, renal, liver, gastrointestinal, psychiatric disorders, pregnancy, malignancy within last 5 years, anemia, coagulopathy requiring anti-coagulation therapy.

Accepts Healthy Volunteers

Yes

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nova Scotia Health	Recruiting	Halifax	Nova Scotia	B4E 0H4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D009767	Obesity, Morbid

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided