A Randomized Study of Approaches in Total Hip Arthroplasty

Total Hip Replacement Clinical Trial

Official title:

A Randomized Clinical Trial of Direct Anterior Approach and Mini-Posterior Approach Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613508
• Other study ID #: 12-001341
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: February 27, 2018

Study information

• Verified date: December 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of the study is to compare the results of an established, successful procedure, which is total hip arthroplasty through a mini-posterior approach to a less studied - increasingly popular procedure, which is total hip replacement through the direct anterior approach utilizing the orthopedic table.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 27, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria

1. Male or Female patients between 20 and 100 with unilateral osteoarthritis (DJD) who are surgical candidates for total hip arthroplasty

2. Study participants must be able to give informed consent.

Exclusion Criteria

1. Significant proximal femoral deformity (post SCFE, Perthes, DDH), acetabular dysplasia (ANY CROWE), inflammatory arthritis, septic arthritis, osteomyelitis, prior infection of hip joint, significant leg length discrepancy (> 4cm), osteoporosis, arthrodesis of the affected hip.

2. The presence of infections, highly communicable diseases, e.g. AIDS, active tuberculosis, venereal disease, hepatitis.

3. Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.

4. Presence of previous prosthetic hip replacement device (any type).

5. Active Metastatic disease

6. Active major Psychiatric illness

7. Active Drug or alcohol abuse

8. BMI > 40.

9. Patients that are known to be pregnant

10. Actively failing contralateral hip replacement.

Related Conditions & MeSH terms

• Total Hip Replacement

Intervention

Procedure:
• Direct Anterior Approach

• Mini-Posterior Approach

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity monitors will be worn	3 monitoring sensors will be worn by the subject.	Baseline to 1 year