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

NCT01807104 | Completed Results

• 1 other identifier: 20091819
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Osteoarthritis of the Hip

Keywords

Anterior Approach; Posterior Approach

Outcome Measures

Primary Outcomes (1)

• Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach

  Harris Hip 5-Year Total Score Change from Baseline. The Harris Hip score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the Harris Hip score, the less dysfunction.This outcome measure has been validated for joint replacement surgery for peer reviewed orthopedic literature.

  5 years

Study Arms (2)

Anterior Approach Total Hip

ACTIVE COMPARATOR

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

Procedure: Anterior Approach / Posterior Approach

Posterior Approach Total Hip

ACTIVE COMPARATOR

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.

Procedure: Anterior versus Posterior Approach for total hip replacement

Interventions

Anterior Approach / Posterior Approach PROCEDURE

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

Anterior Approach Total Hip

Anterior versus Posterior Approach for total hip replacement PROCEDURE

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

Posterior Approach Total Hip

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Barrett, William, M.D.: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Valley Orthopedic Associates

Renton, Washington, 98055, United States

Location

Related Links

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

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Dr. William P. Barrett, MD
• Organization: VOA Research Foundation

wpbarrett@comcast.net

425-656-5060

Study Officials

• William P Barrett, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: William Barrett,M.D,

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: March 8, 2013
• Study Start: January 1, 2010
• Primary Completion: July 20, 2017
• Study Completion: July 20, 2017
• Last Updated: August 29, 2019
• Results First Posted: August 29, 2019

Record last verified: 2019-07

Locations

US (1)