Preoperative Pain, Function, and Activity for Total Hip a... | NCT01248039

Studies
Preoperative Pain, Function, and Activity for Total Hip and Knee Arthroplasty Patients

NCT01248039

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Jul 19, 2012Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Arthroplasty

Interventions

Not provided

Countries

Denmark

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
PRE-THA-TKA	Registry Identifier	H-4-2010-FSP2

Status Module

Record Verification Date

Jul 2012

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

Jan 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Nov 24, 2010

First Submission Date that Met QC Criteria

Nov 24, 2010

First Posted Date

Nov 25, 2010Estimated

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

Jul 18, 2012

Last Update Posted Date

Jul 19, 2012Estimated

Name	Class
Lundbeck Foundation	OTHER

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

This study wish to show if the preoperative level of pain, function or activity for hip and knee arthroplasty patients has any predictive value of the time it takes to fulfill the well-defined discharge criteria.

Detailed Description

The investigators would like to be able to identify those patients, for whom it will take longest time to fulfill the discharge criteria. With this knowledge the investigators will be able to initiate sufficient treatment already before operation.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Total arthroplasty		Patients with osteoarthrosis going for hip or knee arthroplasty

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Leg muscles strength	Maximal muscle force tested for one leg at a time in a Power Rig Mashine	7 months

Secondary Outcomes

Measure	Description	Time Frame
Functional performance	Tested by: Timed Up & Go test, 10 meter fast speed walking test	7 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Total hip arthroplasty patients
Total knee arthroplasty patients

Exclusion Criteria:

Inability to speak and understand Danish
Inability to perform the functional measurements due to other conditions

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

Concesutive hip and knee arthroplasty patients from a department of orthopaedic surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bente Holm, MSc	The Lundbeckcenter for hip and knee surgery, University Hospital at Hvidovre, Kettegaard Allé 30, DK-2650 hvidovre, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, Univerity Hospital at Hvidovre		Hvidovre	Hvidovre	2650	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24954491	Derived	Holm B, Bandholm T, Lunn TH, Husted H, Aalund PK, Hansen TB, Kehlet H. Role of preoperative pain, muscle function, and activity level in discharge readiness after fast-track hip and knee arthroplasty. Acta Orthop. 2014 Sep;85(5):488-92. doi: 10.3109/17453674.2014.934186. Epub 2014 Jun 23.