JointNCT01567696
Clinical, Radiographic and Laboratory Analysis of Failures of Joint Replacements
An observational study of Joint, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to more fully understand the reason(s) that joint replacement implants fail and to better identify diagnosis and outcome methods both pre-operatively and post-operatively with revision surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥18 years of age, that present with a failed joint replacement.
Who may be able to join
- ≥18 years of age
- failed hip or knee replacement
- willing to sign informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UC San Diego Medical Center
San Diego, California, 92103
Scott Ball, MD, 619-657-8200, stball@ucsd.edu
Scott Ball, MD
About this study
Official title: Defining the Inflammatory Cytokines in Patients With Adverse Reactions to Metal-on-Metal Hip Replacements
The purpose of this study is to more fully understand the reason(s) that joint replacement implants fail and to better identify diagnosis and outcome methods both pre-operatively and post-operatively with revision surgery. Analysis of joint replacement failure will include a through analysis of laboratory, radiographic, implant, surgical and demographic data.
Read the detailed description
To examine all clinical data in patients with failed total hip and total knee replacements including patient demographics (age, sex, comorbidities, etc.), patient clinical data (history and physical exam and lab findings) and including implant specifications and radiographic findings (for implant type, implant size, implant bearing surface type, position, stability, etc.).
- Conditions
- Joint
- Keywords
- Revision,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for JointStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Ball, MD, University of California, San Diego
- Investigators
- Scott Ball, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567696
- Sponsor's protocol ID
- IIS-000135/11007
- Status last verified
- Mar 2012
- First submitted
- 28 Mar 2012
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Inflammatory Cytokines in Patients With Adverse Reactions to Metal-on-Metal Hip Replacements
- ClinicalTrials.gov ID
- NCT01567696
- Acronym / sponsor ID
- IIS-000135/11007
- Conditions
- Joint
- Keywords
- Revision,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to more fully understand the reason(s) that joint replacement implants fail and to better identify diagnosis and outcome methods both pre-operatively and post-operatively with revision surgery. Analysis of joint replacement failure will include a through analysis of laboratory, radiographic, implant, surgical and demographic data.
Detailed description
To examine all clinical data in patients with failed total hip and total knee replacements including patient demographics (age, sex, comorbidities, etc.), patient clinical data (history and physical exam and lab findings) and including implant specifications and radiographic findings (for implant type, implant size, implant bearing surface type, position, stability, etc.).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 years of age, that present with a failed joint replacement.
Key inclusion criteria (3 listed)
- ≥18 years of age
- failed hip or knee replacement
- willing to sign informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
Related trials for Joint
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Ball, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott Ball, MD (858-657-8200, stball@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2012.