A Trial Comparing Mini-posterior Approach and Direct Anterior Approach

NCT01024309 | Completed Results DMC

• 1 other identifier: 09072
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis

Keywords

total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Number of Days for Discontinue Assistive Devices

  The primary early functional endpoint is the difference between groups in the postoperative days that patients require any assistive devices for ambulation. Lower number of days indicate better outcomes.

  6 week

Secondary Outcomes (8)

• Harris Hip Score

  3 week

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  3 week

• Abduction Angle

  6 wk

• Anteversion Angle

  6 week

• Harris Hip Score

  6 week

Study Arms (2)

Mini-Posterior Approach

ACTIVE COMPARATOR

Mini-Posterior surgical approach for total hip arthroplasty

Procedure: Mini-Posterior surgical approach for total hip arthroplasty

Direct Anterior Approach

EXPERIMENTAL

Direct Anterior surgical approach for total hip arthroplasty

Procedure: Direct Anterior surgical approach for total hip arthroplasty

Interventions

Mini-Posterior surgical approach for total hip arthroplasty PROCEDURE

Mini-Posterior surgical approach for total hip arthroplasty

Mini-Posterior Approach

Direct Anterior surgical approach for total hip arthroplasty PROCEDURE

Direct Anterior surgical approach for total hip arthroplasty

Direct Anterior Approach

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina, P.A.

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Dr. Susan Odum
• Organization: OrthoCarolina Research Institute

Susan.Odum@OrthoCarolina.com

704.323.2265

Study Officials

• John Bohannon Mason, MD

  OrthoCarolina, P.A.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 30, 2014
• Results First Posted: October 30, 2014

Record last verified: 2014-10

Locations

US (1)