A Trial Comparing Mini-posterior Approach and Direct Anterior Approach
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 25 - 80 |
| Updated: | 5/27/2013 |
| Start Date: | November 2009 |
| End Date: | June 2014 |
| Contact: | Susan Odum, MEd |
| Email: | susan.odum@orthocarolina.com |
| Phone: | 704-323-2265 |
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.
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)
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