Safety of Non-delayed Weight Bearing After Total Hip Repl... | NCT00179088

Studies
Safety of Non-delayed Weight Bearing After Total Hip Replacement With Non-Cemented Fiber Metal Taper Stem

NCT00179088

Sponsor

Vanderbilt University Medical Center

Status

Completed

Last Update Posted

Mar 31, 2017Actual

Enrollment

Phase

Not Applicable

Conditions

Osteoarthritis
Pain

Interventions

Patient may be able to put weight on the operated leg

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
Weight Bearing after THA

Status Module

Record Verification Date

Mar 2017

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

May 2003

Primary Completion Date

Not provided

Completion Date

Nov 2007Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 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

Mar 29, 2017

Last Update Posted Date

Mar 31, 2017Actual

Name	Class
Zimmer Biomet	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to determine if full weight bearing following total hip replacement can speed recovery when the hip replacement in the long bone of the leg is not cemented into the bone. When cement is used, most surgeons allow full or nearly full weight bearing following hip replacement. One drawback to cementless implants has been the restriction of weight bearing for six to eight weeks after surgery, during which time patients are allowed to only put their foot flat on the floor of the operated leg without bearing weight on that leg. This study compares the effect of immediate weight bearing on the speed of recovery from hip replacement surgery in two groups of patients receiving a non-cemented total hip replacement: one group is randomly assigned to not bear weight, and the other group is randomly assigned to allowed, tolerated weight bearing from the day of surgery forward.

Detailed Description

Patients undergoing non-cemented total hip arthroplasty with a Zimmer Fiber Metal Taper Stem and who meet the inclusion and exclusion criteria are offered the informed consent process. Those consenting are randomized following surgery by flip of a coin into one of two groups: Weight Bearing as Tolerated or Toe Touch Weight Bearing Only. Each patient is followed for two years, and is seen at 6 weeks, 3 months, 1 year and two years. Questionnaires are completed including the Harris Hip Score and the SF-36. Patients complete a compliance survey to determine behavior related to their study group assignment and compliance with their study group. Radiographs are obtained at each post-operative interval and subsidence is evaluated and recorded. Range of motion and ambulation are assessed and recorded also.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Patient may be able to put weight on the operated leg	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To learn if clinical and radiographic outcomes differ in two groups of patients after THA.

Secondary Outcomes

Measure	Description	Time Frame
Femoral Stem Subsidence on X-rays at select post-op times.
Return to work status by two years post-operative.
Patient is or is not able to walk without assistive device.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 or older
English Speaking
any form of hip arthritis
primary total hip arthroplasty
willing to sign informed consent

Exclusion Criteria:

under age 18
non-English speaking
critically ill patients
people who are unable to follow-up appropriately due to travel concerns or mental illness.
revision total hip arthroplasty
trochanteric osteotomy
intra-operative fracture
prisoners
not willing to sign informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew A. Shinar, M.D.	Vanderbilt University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37232-8774	United States

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D010146	Pain

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided