CClinicalTrials.gg
CompletedNCT01613508Updated Dec 5, 2018

A Randomized Study of Approaches in Total Hip Arthroplasty

An interventional study of Direct Anterior Approach and Mini-Posterior Approach in Total Hip Replacement, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-12-05.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
20 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Total Hip Replacement
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
116 participants (actual)

Study arms

  • Active comparator
    Direct Anterior Approach

    An oblique incision is made over the anterior margin of the tensor muscle. The fascia of the tensor muscle is identified and incised. The muscle is swept digitally laterally and a retractor is placed over the superior aspect of the femoral neck. The hip capsule is then incised and retracted.

    Procedure: Direct Anterior Approach

  • Active comparator
    Mini-Posterior Approach

    The surgical approach involved a 7 to 9.5 cm incision along the posterior aspect of the femur starting at the tip of the greater trochanter and proceeding distally. The fascia of the gluteus maximus was split, and blunt dissection revealed the underlying abductor and external rotator musculature. The external rotators an the hip capsule were incised and preserved as one layer, with an attempt being made to preserve the insertion of the quadratus femoris on the femur. The hip was dislocated posteriorly and the femoral neck was cut in accordance with the preoperative plan.

    Procedure: Mini-Posterior Approach

Interventions

  • ProcedureDirect Anterior Approach
  • ProcedureMini-Posterior Approach
06

What researchers measure

Primary outcomes

  1. Activity monitors will be worn

    3 monitoring sensors will be worn by the subject.

    Time frame: Baseline to 1 year

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01613508
Lead sponsor
Mayo Clinic
Responsible party
Michael J. Taunton, M.D. (PI, Mayo Clinic) — Principal investigator
First posted
Jun 7, 2012
Start date
Jan 2013
Primary completion
Dec 31, 2017
Completion
Feb 27, 2018
Last update
Dec 5, 2018

Study contacts

Michael Taunton, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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