Hip OsteoarthritisNCT00198003
Addressing Patients' Expectations of Total Hip Arthroplasty in a Randomized Trial
A study testing Educational program to address patients' expectations in people with 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 develop and test an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hip Osteoarthritis, Arthroplasty, Replacement, Hip
- What is being tested?
- Educational program to address patients' expectations
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Sep 2003
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible for this study if they are 55 years of age or older and are scheduled for primary total hip arthroplasty at the Hospital for Special Surgery.
Who cannot join
- Patients will be excluded from this study for the following reasons: if they are not fluent in English; if they are not going to attend the preoperative hip replacement class; if they are unable to complete the surveys; if they refuse to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Addressing Patients Expectations of Total Hip Arthroplasty: Developing and Testing an Educational Intervention in a Randomized Trial
The goals of this study are to develop and test an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty.
Read the detailed description
The first goal of this study is to develop an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty. The intervention will be structured according to the expectations listed in the Hospital for Special Surgery Total Hip Replacement Expectations Survey. The second goal is to test the intervention in a randomized trial. An additional goal is to compare patients' self-reported hip symptoms with radiographic findings.
- Conditions
- Hip Osteoarthritis, Arthroplasty, Replacement, Hip
- Being tested
- Educational program to address patients' expectations
- Keywords
- hip arthritis, total hip arthroplasty, expectations, education
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational program to address patients' expectationsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the within-patient change between pre and post program scores measured by the Hospital for Special Surgery Total Hip Replacement Expectations Survey.
Secondary outcomes (2)
The secondary outcome is to compare patient-reported symptoms with radiographic ratings of disease activity.
The secondary outcome is to assess if patients' expectations after the class coincide with orthopedic surgeons expectations.
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 startNov 2001
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 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
- NCT00198003
- Sponsor's protocol ID
- 99104
- 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, 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, 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, Graziano S, Briskie LM, Peterson MG, Pellicci PM, Salvati EA, Sculco TP. Randomized trials to modify patients' preoperative expectations of hip and knee arthroplasties. Clin Orthop Relat Res. 2008 Feb;466(2):424-31. doi: 10.1007/s11999-007-0052-z. Epub 2008 Jan 10.
PubMed 18196427Mancuso CA, Pavlov H, Hays PL, Sculco TP. Symptoms associated with compartmental radiographic disease in hip arthroplasty patients. J Arthroplasty. 2011 Apr;26(3):439-44. doi: 10.1016/j.arth.2010.01.005. Epub 2010 Mar 23.
PubMed 20334992
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
- Addressing Patients Expectations of Total Hip Arthroplasty: Developing and Testing an Educational Intervention in a Randomized Trial
- ClinicalTrials.gov ID
- NCT00198003
- Acronym / sponsor ID
- 99104
- Conditions
- Hip Osteoarthritis, Arthroplasty, Replacement, Hip
- Keywords
- hip arthritis, total hip arthroplasty, expectations, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Nov 2001
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (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 develop and test an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty.
Detailed description
The first goal of this study is to develop an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty. The intervention will be structured according to the expectations listed in the Hospital for Special Surgery Total Hip Replacement Expectations Survey. The second goal is to test the intervention in a randomized trial. An additional goal is to compare patients' self-reported hip symptoms with radiographic findings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be eligible for this study if they are 55 years of age or older and are scheduled for primary total hip arthroplasty at the Hospital for Special Surgery.
Key exclusion criteria (1 listed)
- Patients will be excluded from this study for the following reasons: if they are not fluent in English; if they are not going to attend the preoperative hip replacement class; if they are unable to complete the surveys; if they refuse to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational program to address patients' expectations | Behavioural | – |
Primary outcome
The primary outcome is the within-patient change between pre and post program scores measured by the Hospital for Special Surgery Total Hip Replacement Expectations Survey.
2 secondary outcomes
The secondary outcome is to compare patient-reported symptoms with radiographic ratings of disease activity.
The secondary outcome is to assess if patients' expectations after the class coincide with orthopedic surgeons expectations.
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 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.
- 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.
- Results publication: PubMed 18196427Mancuso CA, Graziano S, Briskie LM, Peterson MG, Pellicci PM, Salvati EA, Sculco TP. Randomized trials to modify patients' preoperative expectations of hip and knee arthroplasties. Clin Orthop Relat Res. 2008 Feb;466(2):424-31. doi: 10.1007/s11999-007-0052-z. Epub 2008 Jan 10.
- Results publication: PubMed 20334992Mancuso CA, Pavlov H, Hays PL, Sculco TP. Symptoms associated with compartmental radiographic disease in hip arthroplasty patients. J Arthroplasty. 2011 Apr;26(3):439-44. doi: 10.1016/j.arth.2010.01.005. Epub 2010 Mar 23.
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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?
A study testing Educational program to address patients' expectations in people with 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?
The primary outcome is the within-patient change between pre and post program scores measured by the Hospital for Special Surgery Total Hip Replacement Expectations Survey.. 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 NCT00198003, which also lists 7 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.