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

November 30, 2009
June 6, 2013
November 2009
July 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01024309 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Trial Comparing Mini-posterior Approach and Direct Anterior Approach
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
  • Procedure: Mini-Posterior surgical approach for total hip arthroplasty
    Mini-Posterior surgical approach for total hip arthroplasty
  • Procedure: Direct Anterior surgical approach for total hip arthroplasty
    Direct Anterior surgical approach for total hip arthroplasty
  • Active Comparator: Mini-Posterior Approach
    Intervention: Procedure: Mini-Posterior surgical approach for total hip arthroplasty
  • Experimental: Direct Anterior Approach
    Intervention: Procedure: Direct Anterior surgical approach for total hip arthroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
112
July 2013
July 2013   (final data collection date for primary outcome measure)

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)
Both
25 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01024309
09072
Yes
OrthoCarolina Research Institute, Inc.
OrthoCarolina Research Institute, Inc.
Not Provided
Principal Investigator: John Bohannon Mason, MD OrthoCarolina, P.A.
OrthoCarolina Research Institute, Inc.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP