NCT01621932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2017

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

4.8 years

First QC Date

June 14, 2012

Last Update Submit

January 25, 2021

Conditions

Total Hip Arthroplasty

Keywords

Anterior approach

Outcome Measures

Primary Outcomes (1)

  • Hip flexion

    postoperative 4 months

Secondary Outcomes (1)

  • Visual analog scale-pain

    4 months and 12 months post operative

Study Arms (2)

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

Direct anterior approach with capsulectomyPROCEDURE

Direct anterior approach with capsulectomy

Surgical approach 1
Direct anterior approach without capsulectomyPROCEDURE

Direct anterior approach without capsulectomy

Surgical approach 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OrthoCarolina, P.A.

Charlotte, North Carolina, 28207, United States

Location

Study Officials

  • John Masonis, MD

    OrthoCarolina, P.A.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2012

First Posted

June 18, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2016

Study Completion

August 2, 2017

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

US(1)