Surgical Joint Registry MBJRF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Osteoarthritis, Knee, Osteoarthritis, Hip. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Surgical Joint Registry
Overview
The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing joint replacement surgery.
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.
Primary outcome measures
- 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]
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Memorial Bone & Joint Research Foundation — Houston
Identifiers
NCT: NCT03484325 · HSC-GEN-09-0143