Anterior Capsulectomy vs. Repair in Direct Anterior THA | NCT01621932

Studies
Anterior Capsulectomy vs. Repair in Direct Anterior THA

NCT01621932

Sponsor

OrthoCarolina Research Institute, Inc.

Status

Completed

Last Update Posted

Jan 26, 2021Actual

Enrollment

82Actual

Phase

Not Applicable

Conditions

Total Hip Arthroplasty

Interventions

Direct anterior approach with capsulectomy
Direct anterior approach without capsulectomy

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

Status Module

Record Verification Date

Jan 2021

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

Mar 1, 2012Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Aug 2, 2017Actual

First Submitted Date

Jun 14, 2012

First Submission Date that Met QC Criteria

Jun 14, 2012

First Posted Date

Jun 18, 2012Estimated

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

Jan 25, 2021

Last Update Posted Date

Jan 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Randomized prospective study comparing the anterior capsule repair vs capsulectomy with regards to post-operative pain and range of motion outcomes in elective primary unilateral direct anterior approach THA for osteoarthritis. Visual Analog Scores (VAS) will be recorded for preoperative and postoperative months 1 and 4. Hip range of motion will be assessed by goniometer measurements and lateral hip radiographs in maximum flexion.

The purpose of the study is to compare post-operative pain control and hip range of motion between two surgical techniques (anterior capsular repair vs. anterior capsulectomy) during direct anterior total hip arthroplasty.

Detailed Description

Not provided

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

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical approach 1	Active Comparator	Direct anterior surgical approach with capsulectomy	Procedure: Direct anterior approach with capsulectomy
Surgical approach 2	Active Comparator	Direct anterior approach without capsulectomy	Procedure: Direct anterior approach without capsulectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Direct anterior approach with capsulectomy	Procedure	Direct anterior approach with capsulectomy	Surgical approach 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hip flexion		postoperative 4 months

Secondary Outcomes

Measure	Description	Time Frame
Visual analog scale-pain		4 months and 12 months post operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective unilateral primary total hip arthroplasty Direct anterior surgical approach Osteoarthritis diagnosis 18 years of age or older

Exclusion Criteria:

Bilateral primary total hip arthroplasty Revision hip arthroplasty Avascular necrosis of the hip Rheumatoid arthritis of the hip Younger than 18 years of age

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Masonis, MD	OrthoCarolina, P.A.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OrthoCarolina, P.A.		Charlotte	North Carolina	28207	United States