Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach

NCT ID: NCT01807104

Last Updated: 2019-08-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-07-20

Brief Summary

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The purpose of this study is to compare the short term effectiveness and return to function of subjects undergoing primary Total Hip Arthroplasty using an Anterior Approach (incision on the front part of the hip joint) versus Posterior Approach (incision over back part of the hip joint).

Detailed Description

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The anterior approach may provide better early post-operative outcomes because there are fewer muscles at the front of the hip so the surgeon works between them rather than cutting through muscle fibers. However, the anterior approach is more difficult to access so usually requires a specialized table.

The posterior approach is easier to access, but the incision cuts through muscle fiber. This may lengthen recovery time. However, a specialized table, which can be quite expensive, is often not required.

Conditions

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Osteoarthritis of the Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anterior Approach Total Hip

Total hip arthroplasty performed through an anterior surgical approach. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach

Group Type ACTIVE_COMPARATOR

Anterior Approach / Posterior Approach

Intervention Type PROCEDURE

compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach

Posterior Approach Total Hip

The additional arm is the posterior approach total hip, which the Anterior Approach is being compared too. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach.

Group Type ACTIVE_COMPARATOR

Anterior versus Posterior Approach for total hip replacement

Intervention Type PROCEDURE

Compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach

Interventions

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Anterior Approach / Posterior Approach

compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach

Intervention Type PROCEDURE

Anterior versus Posterior Approach for total hip replacement

Compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Subject is able to or capable of providing consent to participate in the clinical investigation.
2. Subject is between the ages of 20-75 years, inclusive.
3. Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD)
4. Subject has sufficient bone stock for the hip replacement device.
5. Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either surgical approach.

Exclusion Criteria

1. Subject in the opinion of the Investigator has an existing condition that would compromise his /her participation and follow-up in this investigation.
2. Subject has had previous surgery on the affected hip.
3. Subject has significant osteoarthritis of the contra-lateral hip requiring a total hip arthroplasty within 12 months.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

Barrett, William, M.D.

INDIV

Sponsor Role lead

Responsible Party

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William Barrett, M.D.

William Barrett,M.D,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William P Barrett, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Valley Orthopedic Associates

Renton, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://doi.org/10.1016/j.arth.2019.01.060

Prospective, Randomized Study of Direct Anterior Approach vs Posterolateral Approach Total Hip Arthroplasty: A Concise 5-Year Follow-Up Evaluation

Other Identifiers

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20091819

Identifier Type: -

Identifier Source: org_study_id

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