Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches

Osteoarthritis Clinical Trial

Official title:

Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01807494
• Other study ID #: LCO.2012.05
• Status: Active, not recruiting
• Phase: N/A
• First received: March 4, 2013
• Last updated: October 5, 2015
• Start date: November 2012
• Est. completion date: February 2023

Study information

• Verified date: October 2015
• Source: New Lexington Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Hip replacement is a common surgical procedure performed to relieve the pain and disability. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the hip with metal and plastic components shaped to allow continued motion of the hip. Surgeons may perform this operation in several different ways. The purpose of this study is to compare two different methods of performing total hip replacement. The investigators hypothesize that subjects treated with the anterior approached may show improved function during the early postoperative period, but that no differences in pain or function will be present after the first postoperative year.

In this study, patients that have elected to have hip replacement and consented to participate in the study will be randomized to have his or her hip replaced using one of two surgical techniques. Subjects will be randomized to be implanted using either an anterior or posterior approach. With the anterior approach, the study surgeon will use an incision that is on the front of the hip, and with the posterior approach, the incision will be more on the backside of your hip. The study surgeon has done more than 300 total hip replacements with both of these techniques.

A baseline assessment will be conducted before hip replacement surgery that includes x-rays, functional tasks like getting up from a chair and stepping down a step, and three questionnaires about the hip, the subject's general health, and how well the subject is able to function. Also, subjects will be required to return to the clinic at several time points after surgery for follow-up visits. Follow-up visits will include hip assessments and questionnaires, as well as follow-up hip x-rays. The follow-up visits will be 6 weeks, 3 months, 1 year, 2 years, 5 years, 7 years, and 10 years after hip replacement surgery. These follow-up visits are part of the study surgeon's normal routine for hip replacement patients, and are not extra visits as a part of this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Between ages of 18 and 85

• End stage hip joint degeneration

• Has elected to undergo primary total hip arthroplasty

Exclusion Criteria:

• Undergoing revision arthroplasty

• Inflammatory or rheumatoid arthritis

• Patients with confounding medical conditions that are not expected to survive for the duration of follow-up (10 years)

• Body Mass Index greater than 40 kg/m2

• Age < 18 or > than 85

• Previous ipsilateral hip surgery including arthroscopic procedures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Avascular Necrosis
• Osteoarthritis

Intervention

Device:
• Total hip replacement components
All patients will receive the same implants

Locations

Country	Name	City	State
United States	Lexington Clinic	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
New Lexington Clinic	Biomet Orthopedics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to discontinued use of an assistive ambulatory device (cane or walker)		6 week postoperative follow-up	Yes
Secondary	modified Harris Hip Score		Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups	No
Secondary	SF-12		Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups	No
Secondary	Lower Extremity Functional Score		Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups	No
Secondary	Functional force testing	Testing to objectively quantify subject function when rising from a chair and descending stairs	Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups	No
Secondary	implant survivorship		1-, 2-, 5-, 7-, and 10-year follow-ups	Yes
Secondary	Length of hospital stay		Collected during the hospital stay (usually 1 to 5 days)	No
Secondary	Operative time		Intra-operative	Yes
Secondary	Number of patients that require blood transfusion		Intra-operative	Yes