Clinical trial NCT03484325: Surgical Joint Registry MBJRF
Official title: Surgical Joint Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Registry
Joint Registry
OA
Osteoarthritis
Osteo arthritis
knee
hip
tka
tha
Lead sponsor: Memorial Bone and Joint Research Foundation
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 990
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hip and knee replacement patients treated by the principal investigator.

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.

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.

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.

Primary outcomes:
measure: Change of Knee Society Scores with KOOS survey
timeFrame: 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
measure: Change of Hip Society Scores with HOOS survey
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Bone & Joint Research Foundation
state: Texas
Study officials:
affiliation: Memorial Bone and Joint Research Foundation
name: Stefan Kreuzer, MD
role: PRINCIPAL_INVESTIGATOR
References: