A Trial Comparing Mini-posterior Approach and Direct Anterior Approach
This study is currently recruiting participants.
Verified January 2012 by OrthoCarolina Research Institute, Inc.
Sponsor:
OrthoCarolina Research Institute, Inc.
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01024309
First received: November 30, 2009
Last updated: October 10, 2012
Last verified: January 2012
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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 |
Resource links provided by NLM:
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: | June 2014 |
| Estimated Primary Completion Date: | June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024309
Contacts
| Contact: Susan Odum, MEd | 704-323-2265 | susan.odum@orthocarolina.com |
| Contact: Christi Cadd, MBA | 704-323-2260 | christi.cadd@orthocarolina.com |
Locations
| United States, North Carolina | |
| OrthoCarolina, P.A. | Recruiting |
| Charlotte, North Carolina, United States, 28207 | |
| Contact: Susan Odum, MEd 704-323-2265 susan.odum@orthocarolina.com | |
| Principal Investigator: John Bohannon Mason, MD | |
| Sub-Investigator: Michael Taunton, MD | |
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: | October 10, 2012 |
| 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 May 22, 2013