Expectations, Satisfaction and Quality of Life in Total H... | NCT00197990

Studies
Expectations, Satisfaction and Quality of Life in Total Hip Arthroplasty

NCT00197990

Sponsor

Hospital for Special Surgery, New York

Status

Completed

Last Update Posted

Nov 23, 2011Estimated

Enrollment

405Actual

Phase

Not provided

Conditions

Hip Osteoarthritis
Arthroplasty, Replacement, Hip

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Arthritis Foundation-NY Chapt

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Jun 2004Actual

Completion Date

Jun 2004Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2011

Last Update Posted Date

Nov 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

405Actual

Measure	Description	Time Frame
Fulfillment of expectations

Measure	Description	Time Frame
Satisfaction with THA

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Patients will be excluded if they are unable to be interviewed, refuse to participate, or are deceased.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who had total hip arthroplasty

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol A Mancuso, MD	Hospital for Special Surgery, New York	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital for Special Surgery		New York	New York	10021	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14566742	Background	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.
9195314	Background	Mancuso 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.

ID	Term
D015207	Osteoarthritis, Hip
D010549	Personal Satisfaction

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases