N/A N=66 Randomized Treatment

A Trial Comparing Mini-posterior Approach and Direct Anterior Approach

Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT01024309 ↗

Enrolled (actual)

Serious AEs

7.4%

Results posted

Oct 2014

Primary outcome: Primary: Number of Days for Discontinue Assistive Devices — 28; 22 days — p=.04

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mini-Posterior surgical approach for total hip arthroplasty (Procedure); Direct Anterior surgical approach for total hip arthroplasty (Procedure)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: OrthoCarolina Research Institute, Inc.
Primary completion: Sep 2013

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 Harris Hip Score	97.5; 98	0.23
SECONDARY WOMAC	97.37; 97.37	0.49
SECONDARY Harris Hip Score	97.5; 98	0.23
SECONDARY WOMAC	97.37; 97.37	0.49

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.

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)

View full record on ClinicalTrials.gov →

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.