NCT00752765

Brief Summary

This project is a prospective observational study that will involve the participation of 25 volunteers that qualify for having knee osteoarthritis, are going to be having gastric bypass surgery and are willing to participate in this study which is designed to last up to two years. Potential candidates will be interviewed using a standard set of questions related to the study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 3, 2015

Status Verified

May 1, 2012

Enrollment Period

2 years

First QC Date

September 11, 2008

Last Update Submit

June 2, 2015

Conditions

Knee PainKnee Osteoarthritis

Keywords

knee osteoarthritisbariatric surgeryweight lossknee pain

Outcome Measures

Primary Outcomes (1)

  • Outcome measures will be determined with the WOMAC and KOOS surveys.

    24 months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be looking at obese patients with co-morbidity of knee osteoarthritis.

You may qualify if:

  • To be included in the study, patients must be between the 18 and 70 years of age
  • Completed a pre-surgery psychological evaluation, and have had intermittent knee pain for at least a year.
  • The bariatric surgery requirement involves a bypass of the stomach.
  • Standard of care guidelines for this surgery require that these patients' previous dieting attempts were without success
  • Medical problems related to obesity, such as diabetes, sleep apnea, hypoventilation, and joint pain.
  • Patients will have a WOMAC pain scale score \> 3, according to the study by Miller, et al.
  • Patients will have a standing AP, lateral and Merchant radiographic scan taken to confirm that they have OA.

You may not qualify if:

  • Patients will be ineligible for the study if any of these criteria are not met.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17070, United States

Location

Related Publications (7)

  • 1. Osteoarthritis of the Knee: State of the Condition. American Academy of Orthopedic Surgeons. 2004. http://www.aaos.org/Research/documents/oainfo_knee.asp.

    BACKGROUND

  • Buckwalter JA, Saltzman C, Brown T. The impact of osteoarthritis: implications for research. Clin Orthop Relat Res. 2004 Oct;(427 Suppl):S6-15. doi: 10.1097/01.blo.0000143938.30681.9d.

    PMID: 15480076BACKGROUND

  • Miller GD, Nicklas BJ, Davis C, Loeser RF, Lenchik L, Messier SP. Intensive weight loss program improves physical function in older obese adults with knee osteoarthritis. Obesity (Silver Spring). 2006 Jul;14(7):1219-30. doi: 10.1038/oby.2006.139.

    PMID: 16899803BACKGROUND

  • Banthin, J. S. and Zodet, M. Trends in the Use and Expenditures for COX-2 Inhibitors and Traditional Nonsteroidal Anti-inflammatory Drugs, 1997-2003. Statistical Brief #139. September 2006. Agency for Healthcare Research and Quality, Rockville, Md. http://www.meps.ahrq.gov/papers/st139/stat139.

    BACKGROUND

  • Blower AL, Brooks A, Fenn GC, Hill A, Pearce MY, Morant S, Bardhan KD. Emergency admissions for upper gastrointestinal disease and their relation to NSAID use. Aliment Pharmacol Ther. 1997 Apr;11(2):283-91. doi: 10.1046/j.1365-2036.1997.d01-604.x.

    PMID: 9146764BACKGROUND

  • Graham GG, Graham RI, Day RO. Comparative analgesia, cardiovascular and renal effects of celecoxib, rofecoxib and acetaminophen (paracetamol). Curr Pharm Des. 2002;8(12):1063-75. doi: 10.2174/1381612023394917.

    PMID: 11945151BACKGROUND

  • Aw TJ, Haas SJ, Liew D, Krum H. Meta-analysis of cyclooxygenase-2 inhibitors and their effects on blood pressure. Arch Intern Med. 2005 Mar 14;165(5):490-6. doi: 10.1001/archinte.165.5.IOI50013. Epub 2005 Feb 14.

    PMID: 15710786BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeWeight Loss

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ann M. Rogers, M.D.

    Penn State Milton S. Hershey Medical Center, Dept of Surgery

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair, Orthopaedics and Rehabilitation

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 15, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

June 3, 2015

Record last verified: 2012-05

Locations

US(1)