ObesityNCT00194051
Symptomatic, Biomechanical and Radiographic Outcomes in Knee Osteoarthritis Following Gastric Bypass Surgery
An observational study of Obesity and Osteoarthritis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Obesity, Osteoarthritis
- What is being tested?
- gastric bypass surgery
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to 1 May 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing gastric bypass surgery At least 35 years old
- -
Who cannot join
- Inability to walk unassisted Pain affecting gait in any lower extremity joint
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
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.
Read the 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.
- Conditions
- Obesity, Osteoarthritis
- Being tested
- gastric bypass surgery
- Keywords
- obesity, gait biomechanics, knee osteoarthritis
- Medical subject headings
- Obesity, Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric bypass surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completion1 May 2006
- Study completion1 May 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Elizabeth Severance Prentiss Foundation
- Responsible party
- Sponsor
- Investigators
- Michele M Hooper, MD, MS, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194051
- Sponsor's protocol ID
- 02-03-10
- Status last verified
- Aug 2022
- First submitted
- 13 Sep 2005
- Last updated
- 26 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic, Biomechanical and Radiographic Outcomes in Knee Osteoarthritis Following Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT00194051
- Acronym / sponsor ID
- 02-03-10
- Conditions
- Obesity, Osteoarthritis
- Keywords
- obesity, gait biomechanics, knee osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Elizabeth Severance Prentiss Foundation
- Study start
- Feb 2003 (actual)
- Primary completion
- 1 May 2006 (actual)
- Study completion
- 1 May 2006 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Undergoing gastric bypass surgery At least 35 years old
- -
Key exclusion criteria (2 listed)
- Inability to walk unassisted Pain affecting gait in any lower extremity joint
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastric bypass surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele M Hooper, MD, MS principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Osteoarthritis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.