Osteoarthritis
Conditions
Keywords
total hip arthroplasty
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.
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.
Interventions
PROCEDUREMini-Posterior surgical approach for total hip arthroplasty
Mini-Posterior surgical approach for total hip arthroplasty
PROCEDUREDirect Anterior surgical approach for total hip arthroplasty
Direct Anterior surgical approach for total hip arthroplasty
Sponsors
OrthoCarolina Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days for Discontinue Assistive Devices | 6 week | 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
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 3 week | 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) | 3 week | 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 | 6 wk | 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 | 6 week | 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. |
| WOMAC | 6 week | 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. |
Countries
United States
Participant flow
Recruitment details
66 volunteer participants were enrolled during routine clinical practice of the principal investigator between the dates of 12/8/2009 and 10/9/2012.
Pre-assignment details
12 patients withdrew participation prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| Mini-Posterior Approach Mini-Posterior surgical approach for total hip arthroplasty | 35 |
| Direct Anterior Approach Direct Anterior surgical approach for total hip arthroplasty | 31 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 4 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Direct Anterior Approach | Mini-Posterior Approach | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 17 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 18 Participants | 35 Participants |
| Age, Continuous | 63.4 years STANDARD_DEVIATION 8.6 | 64.2 years STANDARD_DEVIATION 9.4 | 63.8 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 31 participants | 35 participants | 66 participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Male | 15 Participants | 17 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 27 | 1 / 27 |
| serious Total, serious adverse events | 3 / 27 | 1 / 27 |
Outcome results
Primary
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.
Time frame: 6 week
Population: A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mini-Posterior Approach | Number of Days for Discontinue Assistive Devices | 28 days |
| Direct Anterior Approach | Number of Days for Discontinue Assistive Devices | 22 days |
p-value: 0.04Wilcoxon (Mann-Whitney)
Secondary
Abduction Angle
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.
Time frame: 6 wk
Population: A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mini-Posterior Approach | Abduction Angle | 40 degrees |
| Direct Anterior Approach | Abduction Angle | 38 degrees |
p-value: 0.22Wilcoxon (Mann-Whitney)
Secondary
Anteversion Angle
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.
Time frame: 6 week
Population: A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mini-Posterior Approach | Anteversion Angle | 29 degrees |
| Direct Anterior Approach | Anteversion Angle | 26 degrees |
p-value: 0.0029Wilcoxon (Mann-Whitney)
Secondary
Harris Hip Score
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).
Time frame: 3 week
Population: A total of 53 participants returned for follow-up at 3 weeks. The remaining patients did not return to the clinic for follow-up at 3 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mini-Posterior Approach | Harris Hip Score | 81 units on a scale |
| Direct Anterior Approach | Harris Hip Score | 86.5 units on a scale |
p-value: 0.08Wilcoxon (Mann-Whitney)
Secondary
Harris Hip Score
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).
Time frame: 6 week
Population: 54 participants returned for follow-up at 6 weeks. A total of 5 participants did not complete the Harris Hip Score instrument in its entirety at this appointment and, thus, were excluded from the analysis. The remaining patients did not return to the clinic for follow-up at 6 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mini-Posterior Approach | Harris Hip Score | 93 units on a scale |
| Direct Anterior Approach | Harris Hip Score | 97 units on a scale |
p-value: 0.13Wilcoxon (Mann-Whitney)
Secondary
Harris Hip Score
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).
Time frame: 12 month
Population: A total of 37 participants returned for follow-up at 12 months. The remaining patients did not return to the clinic for follow-up at 12 months.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mini-Posterior Approach | Harris Hip Score | 97.5 units on a scale |
| Direct Anterior Approach | Harris Hip Score | 98 units on a scale |
p-value: 0.23Wilcoxon (Mann-Whitney)
Secondary
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
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.
Time frame: 3 week
Population: A total of 53 participants returned for follow-up at 3 weeks. The remaining patients did not return to the clinic for follow-up at 3 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mini-Posterior Approach | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 91.48 units on a scale |
| Direct Anterior Approach | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 87.20 units on a scale |
p-value: 0.04Wilcoxon (Mann-Whitney)
Secondary
WOMAC
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.
Time frame: 6 week
Population: A total of 54 participants returned for follow-up at 6 weeks. 3 participants did not complete the WOMAC in its entirety at this appointment and, thus, were excluded from the analysis. The remaining patients did not return to the clinic for follow-up at 6 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mini-Posterior Approach | WOMAC | 95.72 units on a scale |
| Direct Anterior Approach | WOMAC | 95.41 units on a scale |
p-value: 0.29Wilcoxon (Mann-Whitney)
Secondary
WOMAC
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.
Time frame: 12 month
Population: A total of 37 participants returned for follow-up at 12 months. The remaining patients did not return to the clinic for follow-up at 12 months.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mini-Posterior Approach | WOMAC | 97.37 units on a scale |
| Direct Anterior Approach | WOMAC | 97.37 units on a scale |
p-value: 0.49Wilcoxon (Mann-Whitney)