Symptomatic, Biomechanical and Radiographic Outcomes in K... | NCT00194051

Studies
Symptomatic, Biomechanical and Radiographic Outcomes in Knee Osteoarthritis Following Gastric Bypass Surgery

NCT00194051

Sponsor

University Hospitals Cleveland Medical Center

Status

Completed

Last Update Posted

Aug 26, 2022Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Obesity
Osteoarthritis

Interventions

gastric bypass surgery

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

Aug 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

Feb 2003Actual

Primary Completion Date

May 1, 2006Actual

Completion Date

May 1, 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

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 23, 2022

Last Update Posted Date

Aug 26, 2022Actual

Name	Class
Elizabeth Severance Prentiss Foundation	OTHER

Description Module

Brief Summary

Weight is a risk factor for knee osteoarthritis

Knee osteoarthritis is associated with abnormal gait biomechanics

Gait biomechanics are evaluated in gastric bypass patients before and after losing 100 pounds.

Detailed Description

Weight is a major risk factor for development of knee osteoarthritis, but not hip or ankle arthritis. One possible mechanism for this is the generation of abnormal gait biomechanics secondary to obesity that are conducive to the development of knee osteoarthritis.

We evaluate gait biomechanics, knee symptoms and knee radiographs in 35 obese patients before and after gastric bypass surgery to determine the effect of significant weight loss on gait biomechanics, knee symptoms and knee radiographs.

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

No data available

No data is available for this block.

Enrollment

35Actual

Name	Type	Description	Arm Group Labels	Other Names
gastric bypass surgery	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergoing gastric bypass surgery At least 35 years old

Exclusion Criteria:

Inability to walk unassisted Pain affecting gait in any lower extremity joint

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michele M Hooper, MD, MS	University Hospitals Cleveland Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Cleveland		Cleveland	Ohio	44106	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D010003	Osteoarthritis
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided