We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Surgical Joint Registry MBJRF (MBJRFREG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03484325
Recruitment Status : Enrolling by invitation
First Posted : March 30, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Stefan Kreuzer MD, Memorial Bone and Joint Research Foundation

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing joint replacement surgery.

Condition or disease
Osteoarthritis, Knee Osteoarthritis, Hip

Detailed Description:
This is a registry database. Consented subjects will have their medical data collected via a patient questionnaire in either paper or web based application form. Data will be collected prospectively and retrospectively and will be entered into the database generated by Memorial Bone and Joint Research Foundation. Collection of data will start during the initial clinic visit as part of standard of care. Subjects will be asked to fill out a 4-page "pre-operative hip questionnaire" or "pre-operative knee questionnaire", which includes questions for self-assessment from the Hip Disability and Osteoarthritis Outcome Score (HOOS), Knee disability and Osteoarthritis Outcome Score (KOOS), EQ-5D and University of California, Los Angeles Activity (UCLA) questionnaires. Demographic, intra-operative and additional data will also be collected to correctly identify the subject's specific disease process and treatment plan. Subjects will be asked to fill out a post-operative hip and knee questionnaire that is similar to the pre-operative questionnaire to evaluate the improvement in their clinical outcomes. The subjects will be requested to complete the post-operative questionnaires at 6 months and annually thereafter.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 990 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Surgical Joint Registry
Study Start Date : May 2009
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change of Knee Society Scores with KOOS survey [ Time Frame: Pre-operatively (baseline) and at 6 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months ]

    The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing knee replacement surgery.

    These clinical outcomes will be assessed by using the KSS along with the KOOS survey for knee replacement cases. The scores obtained at each time point will be compared to the baseline. Therefore the outcome is the change of scores over time.


  2. Change of Hip Society Scores with HOOS survey [ Time Frame: Pre-operatively (baseline) and at 6 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months ]

    The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing hip replacement surgery.

    These clinical outcomes will be assessed by using the HSS for hips along with the HOOS survey for hip replacement cases. The scores obtained at each time point will be compared to the baseline. Therefore the outcome is the change of scores over time.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Hip and knee replacement patients treated by the principal investigator.
Criteria

Inclusion Criteria:

  • Inclusion criteria will be limited to subjects who have consented to undergo elective total joint replacement, hip resurfacing and partial knee surgery, arthroscopy and Femoro-actabular impingement (FAI) release performed by the PI.
  • All patients of legal adult age will be eligible for the study. All patients will have an equal chance to participate in the study regardless of race or gender. Patients will be enrolled in the order as they are diagnosed by the PI.

Exclusion Criteria:

  • Exclusion criteria will be limited to morbid obesity, active infection, heart failure, lung failure, severe bleeding abnormalities, subject with known metal allergy, subject who cannot legally decide for themselves.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484325


Locations
Layout table for location information
United States, Texas
Memorial Bone & Joint Research Foundation
Houston, Texas, United States, 77043
Sponsors and Collaborators
Memorial Bone and Joint Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Stefan Kreuzer, MD Memorial Bone and Joint Research Foundation
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Stefan Kreuzer MD, President, Memorial Bone and Joint Research Foundation
ClinicalTrials.gov Identifier: NCT03484325    
Other Study ID Numbers: HSC-GEN-09-0143
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Keywords provided by Stefan Kreuzer MD, Memorial Bone and Joint Research Foundation:
Registry
Joint Registry
OA
Osteoarthritis
Osteo arthritis
 knee
hip
tka
tha
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases