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A Trial Comparing Mini-posterior Approach and Direct Anterior Approach

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01024309
First received: November 30, 2009
Last updated: October 28, 2014
Last verified: October 2014
  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

Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • Number of Days for Discontinue Assistive Devices [ Time Frame: 6 week ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: 3 week ] [ Designated as safety issue: No ]
    The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0-44 points), function (0-47 points), absence of deformity (4 points), and range of motion (5 points).

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 3 week ] [ Designated as safety issue: No ]
    Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.

  • Abduction Angle [ Time Frame: 6 wk ] [ Designated as safety issue: No ]
    Abduction angle is a radiographic measure of implant position. 40 degrees of abduction is optimal. 30-50 degrees of anteversion indicates correct placement of prosthetic joint. Values closer to 40 degrees indicate better placement.

  • Anteversion Angle [ Time Frame: 6 week ] [ Designated as safety issue: No ]
    Anteversion angle is a radiographic measure of implant position. 35 degrees of anteversion is optimal. 25-45 degrees of anteversion indicates correct placement of prosthetic joint. Values closer to 35 degrees indicate better placement.

  • Harris Hip Score [ Time Frame: 6 week ] [ Designated as safety issue: No ]
    The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0-44 points), function (0-47 points), absence of deformity (4 points), and range of motion (5 points).

  • WOMAC [ Time Frame: 6 week ] [ Designated as safety issue: No ]
    Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.

  • Harris Hip Score [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0-44 points), function (0-47 points), absence of deformity (4 points), and range of motion (5 points).

  • WOMAC [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.


Enrollment: 66
Study Start Date: November 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mini-Posterior Approach
Mini-Posterior surgical approach for total hip arthroplasty
Procedure: Mini-Posterior surgical approach for total hip arthroplasty
Mini-Posterior surgical approach for total hip arthroplasty
Experimental: Direct Anterior Approach
Direct Anterior surgical approach for total hip arthroplasty
Procedure: Direct Anterior surgical approach for total hip arthroplasty
Direct Anterior surgical approach for total hip arthroplasty

Detailed Description:

A number of studies have compared surgical approach for total hip arthroplasty. The influence of surgical outcome as a function of approach comparing mini-posterior to direct anterior has not been reported in a randomized, prospective manner.

Standard primary total hip arthroplasty (THA) can reliably alleviate pain, improve function, and improve the quality of life in a broad section of patients with end stage arthrosis of the hip. However, minimally invasive approaches, such as the direct anterior and mini-posterior approaches, have been devised with the goal of decreasing peri-operative pain, speed early postoperative function, and improve patient satisfaction with the procedure, compared with standard THA. These patient centered goals are combined with the surgeon's desire of a safe, reproducible minimally invasive procedure that has durable, properly positioned components.

There are currently no prospective, randomized studies comparing the direct anterior approach to total hip arthroplasty with other minimally invasive approaches. The mini-posterior approach has been studied extensively, with promising results. Others have compared the mini-posterior approach with other minimally invasive procedures, and at the current time, has the most prospective data demonstrating its superiority as a minimally invasive approach. Pagnano performed a prospective, randomized trial comparing the early clinical results of mini -posterior THA with Two-incision THA. The results found that the early attainment of functional milestones was shorter in the mini-posterior group.

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

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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024309

Locations
United States, North Carolina
OrthoCarolina, P.A.
Charlotte, North Carolina, United States, 28207
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
Results First Received: December 31, 2013
Last Updated: October 28, 2014
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 November 25, 2014