Trial Outcomes & Findings for Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach (NCT NCT01807104)
NCT ID: NCT01807104
Last Updated: 2019-08-29
Results Overview
Harris Hip 5-Year Total Score Change from Baseline. The Harris Hip score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the Harris Hip score, the less dysfunction.This outcome measure has been validated for joint replacement surgery for peer reviewed orthopedic literature.
COMPLETED
NA
87 participants
5 years
2019-08-29
Participant Flow
Participant milestones
| Measure |
Direct Anterior Approach
Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed.
|
Postero-Lateral Approach
Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
44
|
|
Overall Study
COMPLETED
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach
Baseline characteristics by cohort
| Measure |
Direct Anterior Approach
n=43 Participants
Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed.
|
Postero-Lateral Approach
n=44 Participants
Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 9.0 • n=99 Participants
|
63.0 years
STANDARD_DEVIATION 8.0 • n=107 Participants
|
62.1 years
STANDARD_DEVIATION 8.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5 yearsHarris Hip 5-Year Total Score Change from Baseline. The Harris Hip score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the Harris Hip score, the less dysfunction.This outcome measure has been validated for joint replacement surgery for peer reviewed orthopedic literature.
Outcome measures
| Measure |
Direct Anterior Approach
n=38 Participants
Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed.
|
Postero-Lateral Approach
n=40 Participants
Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery.
|
|---|---|---|
|
Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach
|
40.1 score on a scale
Standard Deviation 10.89
|
43.8 score on a scale
Standard Deviation 15.94
|
Adverse Events
Direct Anterior Approach
Postero-Lateral Approach
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Direct Anterior Approach
n=43 participants at risk
Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed.
|
Postero-Lateral Approach
n=44 participants at risk
Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
9.3%
4/43 • Number of events 4 • 8 years
|
4.5%
2/44 • Number of events 2 • 8 years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.3%
1/43 • Number of events 1 • 8 years
|
9.1%
4/44 • Number of events 4 • 8 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place