A Trial Comparing Mini-posterior Approach and Direct Anterior Approach

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by OrthoCarolina Research Institute, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01024309
First received: November 30, 2009
Last updated: June 6, 2013
Last verified: January 2012
  Purpose

The purpose is to determine if differences exist in the attainment of functional milestones that reflect activities of daily living between mini-posterior and direct anterior approach total hip arthroplasty (THA). The investigators also hope to determine if the general health outcome after direct anterior total hip arthroplasty was better than that after mini-posterior-incision total hip arthroplasty as measured with Short Form-12 (SF-12) scores, and to evaluate variation of surgical factors of the two procedures on the basis of the operative time, component positioning, and occurrence of early complications.


Condition Intervention
Osteoarthritis
Procedure: Mini-Posterior surgical approach for total hip arthroplasty
Procedure: Direct Anterior surgical approach for total hip arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Clinical Trial Comparing the Clinical Outcomes Following Total Hip Arthroplasty by a Single Surgeon Using Either a Mini-posterior Approach or a Direct Anterior Approach

Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • The primary early functional endpoint is the difference between groups in the postoperative days that patients require any assistive devices for ambulation. [ Time Frame: 3 wk, 6 wk, 12 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The postoperative rate of improvement in functional outcome as measured by the Harris Hip Score (HHS), WOMAC (Western Ontario), and SF-12 over time. [ Time Frame: 3 wk, 6 wk and 12 mo ] [ Designated as safety issue: No ]
  • The difference between groups with respect to implant position and leg length. [ Time Frame: 3 wk, 6 wk, 12 mo ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: November 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mini-Posterior Approach Procedure: Mini-Posterior surgical approach for total hip arthroplasty
Mini-Posterior surgical approach for total hip arthroplasty
Experimental: Direct Anterior Approach Procedure: Direct Anterior surgical approach for total hip arthroplasty
Direct Anterior surgical approach for total hip arthroplasty

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is willing and able to understand, sign and date the study specific Patient Informed Consent and HIPAA authorization to volunteer participation in the study.
  • The subject is between 25 and 80 years of age at the time of surgery.
  • The subject has elected to undergo primary total hip arthroplasty for osteoarthritis.
  • The subject is psychosocially, mentally and physically able to comply with the requirements of the study including post-operative clinical, radiographic evaluations and completion of patient questionnaires.
  • The subject is skeletally mature.

Exclusion Criteria:

  • The subject has a BMI greater than 35.
  • The subject has had a previous total hip arthroplasty.
  • The subject has inflammatory arthritis.
  • The subject has any type of infection.
  • The subject has developmental dysplasia of the hip.
  • The subject has a known metal allergy.
  • The subject has an extreme offset of greater than 50 mm.
  • The subject has an acetabular deformity requiring advanced reconstructive techniques.
  • The subject has Charcot's disease.
  • The subject has Paget's disease
  • Dependence on narcotics for 6 months (or longer)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024309

Locations
United States, North Carolina
OrthoCarolina, P.A.
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Investigators
Principal Investigator: John Bohannon Mason, MD OrthoCarolina, P.A.
  More Information

No publications provided

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01024309     History of Changes
Other Study ID Numbers: 09072
Study First Received: November 30, 2009
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by OrthoCarolina Research Institute, Inc.:
total hip arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014