Hip OsteoarthritisNCT00197990
Expectations, Satisfaction and Quality of Life in Total Hip Arthroplasty
An observational study of Hip Osteoarthritis and Arthroplasty, Replacement, Hip, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The goals of this study are to identify predictors of improvement in quality of life and satisfaction with total hip arthroplasty three to five years after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Arthroplasty, Replacement, Hip
- How many people
- 405 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jun 2004
- 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 who had total hip arthroplasty
Who may be able to join
- Patients will be eligible for this study if they are part of an assembled cohort of patients who underwent primary unilateral or bilateral total hip arthroplasty in 1998-2000 at the Hospital for Special Surgery.
Who cannot join
- Patients will be excluded if they are unable to be interviewed, refuse to participate, or are deceased.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
The goals of this study are to identify predictors of improvement in quality of life and satisfaction with total hip arthroplasty three to five years after surgery.
Read the detailed description
The goals of this study are to identify predictors of improvement in quality of life and satisfaction with total hip arthroplasty three to five years after surgery. Predictors that will be considered are variables that were obtained prospectively and systematically at the time of surgery, including demographic characteristics, functional status, expectations, perioperative complications, and comorbidity. At the follow-up functional status and patient satisfaction will be measured, as well as fulfillment of expectations and predispositional factors.
- Conditions
- Hip Osteoarthritis, Arthroplasty, Replacement, Hip
- Keywords
- total hip arthroplasty, expectations, satisfaction, quality of life
- Medical subject headings
- Osteoarthritis, Hip, Personal Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Fulfillment of expectations
Secondary outcomes (1)
Satisfaction with THA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carol A Mancuso, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197990
- Sponsor's protocol ID
- 22078
- Other IDs
- Arthritis Foundation-NY Chapt
- Status last verified
- Nov 2011
- First submitted
- 12 Sep 2005
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Mancuso CA, Sculco TP, Salvati EA. Patients with poor preoperative functional status have high expectations of total hip arthroplasty. J Arthroplasty. 2003 Oct;18(7):872-8. doi: 10.1016/s0883-5403(03)00276-6.
PubMed 14566742Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME. Patients' expectations and satisfaction with total hip arthroplasty. J Arthroplasty. 1997 Jun;12(4):387-96. doi: 10.1016/s0883-5403(97)90194-7.
PubMed 9195314Mancuso CA, Ranawat CS, Esdaile JM, Johanson NA, Charlson ME. Indications for total hip and total knee arthroplasties. Results of orthopaedic surveys. J Arthroplasty. 1996 Jan;11(1):34-46. doi: 10.1016/s0883-5403(96)80159-8.
PubMed 8676117Blake VA, Allegrante JP, Robbins L, Mancuso CA, Peterson MG, Esdaile JM, Paget SA, Charlson ME. Racial differences in social network experience and perceptions of benefit of arthritis treatments among New York City Medicare beneficiaries with self-reported hip and knee pain. Arthritis Rheum. 2002 Aug;47(4):366-71. doi: 10.1002/art.10538.
PubMed 12209481Peterson MG, Hollenberg JP, Szatrowski TP, Johanson NA, Mancuso CA, Charlson ME. Geographic variations in the rates of elective total hip and knee arthroplasties among Medicare beneficiaries in the United States. J Bone Joint Surg Am. 1992 Dec;74(10):1530-9.
PubMed 1469013Mancuso CA, Jout J, Salvati EA, Sculco TP. Fulfillment of patients' expectations for total hip arthroplasty. J Bone Joint Surg Am. 2009 Sep;91(9):2073-8. doi: 10.2106/JBJS.H.01802.
PubMed 19723982
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expectations, Satisfaction and Quality of Life in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00197990
- Acronym / sponsor ID
- 22078
- Conditions
- Hip Osteoarthritis, Arthroplasty, Replacement, Hip
- Keywords
- total hip arthroplasty, expectations, satisfaction, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 20 Sep 2005 (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 goals of this study are to identify predictors of improvement in quality of life and satisfaction with total hip arthroplasty three to five years after surgery.
Detailed description
The goals of this study are to identify predictors of improvement in quality of life and satisfaction with total hip arthroplasty three to five years after surgery. Predictors that will be considered are variables that were obtained prospectively and systematically at the time of surgery, including demographic characteristics, functional status, expectations, perioperative complications, and comorbidity. At the follow-up functional status and patient satisfaction will be measured, as well as fulfillment of expectations and predispositional factors.
Study design
- Observational model
- Cohort
- 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 who had total hip arthroplasty
Key inclusion criteria (1 listed)
- Patients will be eligible for this study if they are part of an assembled cohort of patients who underwent primary unilateral or bilateral total hip arthroplasty in 1998-2000 at the Hospital for Special Surgery.
Key exclusion criteria (1 listed)
- Patients will be excluded if they are unable to be interviewed, refuse to participate, or are deceased.
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
Fulfillment of expectations
1 secondary outcome
Satisfaction with THA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
- Background: PubMed 14566742Mancuso CA, Sculco TP, Salvati EA. Patients with poor preoperative functional status have high expectations of total hip arthroplasty. J Arthroplasty. 2003 Oct;18(7):872-8. doi: 10.1016/s0883-5403(03)00276-6.
- Background: PubMed 9195314Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME. Patients' expectations and satisfaction with total hip arthroplasty. J Arthroplasty. 1997 Jun;12(4):387-96. doi: 10.1016/s0883-5403(97)90194-7.
- Background: PubMed 8676117Mancuso CA, Ranawat CS, Esdaile JM, Johanson NA, Charlson ME. Indications for total hip and total knee arthroplasties. Results of orthopaedic surveys. J Arthroplasty. 1996 Jan;11(1):34-46. doi: 10.1016/s0883-5403(96)80159-8.
- Background: PubMed 12209481Blake VA, Allegrante JP, Robbins L, Mancuso CA, Peterson MG, Esdaile JM, Paget SA, Charlson ME. Racial differences in social network experience and perceptions of benefit of arthritis treatments among New York City Medicare beneficiaries with self-reported hip and knee pain. Arthritis Rheum. 2002 Aug;47(4):366-71. doi: 10.1002/art.10538.
- Background: PubMed 1469013Peterson MG, Hollenberg JP, Szatrowski TP, Johanson NA, Mancuso CA, Charlson ME. Geographic variations in the rates of elective total hip and knee arthroplasties among Medicare beneficiaries in the United States. J Bone Joint Surg Am. 1992 Dec;74(10):1530-9.
- Results publication: PubMed 19723982Mancuso CA, Jout J, Salvati EA, Sculco TP. Fulfillment of patients' expectations for total hip arthroplasty. J Bone Joint Surg Am. 2009 Sep;91(9):2073-8. doi: 10.2106/JBJS.H.01802.
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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.
Carol A Mancuso, MD principal investigator
Hospital for Special Surgery, New York
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 Hip Osteoarthritis and Arthroplasty, Replacement, Hip, run by Hospital for Special Surgery, New York 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 1 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: finished, as of the sponsor's last update on 23 Nov 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fulfillment of expectations. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00197990, which also lists 6 linked publications.
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 23 Nov 2011.