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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

87 participants

Primary outcome timeframe

5 years

Results posted on

2019-08-29

Participant Flow

Participant milestones

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

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 years

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.

Outcome measures

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

Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths

Postero-Lateral Approach

Serious events: 0 serious events
Other events: 6 other events
Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Dr. William P. Barrett, MD

VOA Research Foundation

Phone: 425-656-5060

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place