NCT05120492

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
14mo left

Started Apr 2022

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Apr 2022Jul 2027

First Submitted

Initial submission to the registry

November 3, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

April 22, 2022

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

5.2 years

First QC Date

November 3, 2021

Last Update Submit

August 19, 2024

Conditions

Knee OsteoarthritisMorbid Obesity

Keywords

Arthroplasty, Replacement, KneeBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • Pain, mobility and quality of Life

    Knee Injury and Osteoarthritis Outcome Score (KOOS4)

    1 year

Secondary Outcomes (1)

  • EuroQol Group 5-Dimension Self Report Questionnaire (EQ-5D)

    1 year

Study Arms (2)

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

bariatric surgery followed by total knee replacementPROCEDURE

The only intervention is the randomization of the priority of the 2 procedures.

Surgical weight loss

Eligibility Criteria

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

You may qualify if:

  • severe knee osteoarthritis body-mass index of 45 to 60

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Health

Halifax, Nova Scotia, B4E 0H4, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeObesity, Morbid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2021

First Posted

November 15, 2021

Study Start

April 22, 2022

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations

CA(1)