NCT03484325

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
990

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress79%
May 2009Dec 2030

Study Start

First participant enrolled

May 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2011

Completed
6.7 years until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

11.6 years

First QC Date

July 22, 2011

Last Update Submit

August 13, 2019

Conditions

Keywords

RegistryJoint RegistryOAOsteoarthritisOsteo arthritiskneehiptkatha

Outcome Measures

Primary Outcomes (2)

  • Change of Knee Society Scores with KOOS survey

    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.

    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

    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.

    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

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hip and knee replacement patients treated by the principal investigator.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Bone & Joint Research Foundation

Houston, Texas, 77043, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, HipOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Stefan Kreuzer, MD

    Memorial Bone and Joint Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

July 22, 2011

First Posted

March 30, 2018

Study Start

May 1, 2009

Primary Completion

December 1, 2020

Study Completion (Estimated)

December 1, 2030

Last Updated

August 15, 2019

Record last verified: 2019-08

Locations