N/A
Completed N=66
A Trial Comparing Mini-posterior Approach and Direct Anterior Approach
Source: ClinicalTrials.gov NCT01024309 ↗Enrolled (actual)
66
Serious AEs
7.4%
Results posted
Oct 2014
Primary outcomePrimary: Number of Days for Discontinue Assistive Devices — 28; 22 days — p=.04
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days for Discontinue Assistive Devices |
28; 22 | .04 sig |
| SECONDARY Harris Hip Score |
97.5; 98 | 0.23 |
| SECONDARY Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
91.48; 87.20 | 0.04 sig |
| SECONDARY Abduction Angle |
40; 38 | 0.22 |
| SECONDARY Anteversion Angle |
29; 26 | .0029 sig |
| SECONDARY WOMAC |
97.37; 97.37 | 0.49 |
Eligibility Criteria
Inclusion Criteria
- The subject is willing and able to understand, sign and date the study specific Patient Informed Consent and Health Insurance Portability and Accountability Act (HIPPA) 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)
Data sourced from ClinicalTrials.gov (NCT01024309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.