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Clinical Trials/CTRI/2022/11/047482
CTRI/2022/11/047482
Completed
Phase 2

Clinicoradiological outcomes and patient satisfaction following total hip arthroplasty via direct anterior approach vs posterior approach (a prospective randomized controlled trial)

NA1 site in 1 country60 target enrollmentStarted: November 30, 2022Last updated:

Overview

Phase
Phase 2
Status
Completed
Sponsor
NA
Enrollment
60
Locations
1
Primary Endpoint
2 Clinical outcome: Compare overall clinical outcomes between two group using Harris Hip Score and WOMAC score

Overview

Brief Summary

Total hip arthroplasty (THA) is one of the commonly performedsurgeries in orthopedics. THA is performed for various indications likeend-stage degenerative hip osteoarthritis (OA), hip osteonecrosis (ON),congenital hip disorders, post-traumatic arthritis of hip, inflammatoryarthropathies of hip. It is done for pain relief, functional restoration andoverall improvement in quality of life. Hip osteoarthritis (OA) is the mostprevalent and disabling conditions affecting the elderly. There is an estimated25% lifetime risk of symptomatic hip OA in people who live to age 85 years.

There are 3 classic approaches forTHA, each with advantages and disadvantages: the Direct Anterior Approach, the PosteriorApproach and the Lateral Approach.

Thedirect anterior approach to the hip was originally described by Carl Heuter in1881. Smith-Peterson had frequently used this approach and modified over theyears and popularized this approach in 1920s-1930s. The anterior-based incisionutilizes the interval between the tensor fascia lata and the sartorius muscles. The main advantageof the approach to be the muscle-sparing nature, earlier restoration of gait kinematicsand low dislocation rates. The direct anterior approach can beperformed with or without the use of a specialized table. Mainchallenges in anterior approach is limited exposure, difficulty in obesepatient, and duration of surgery increases due to limited exposure, also it hassteep learning curve.

The posterior approach to the hip waspopularized by Moore in the 1950s. The posterior approach is the most commonsurgical approach used globally for THAs. It providesadequate visualization of both the acetabulum and femur during bothreconstructive procedures. The approach spares the abductor muscles duringsurgical exposure of the acetabulum and femur. Main drawback ofposterior approach was dislocation due to cutting of short external rotators ofhip. However, dislocation became less common with the PA because of enhanced capsularclosure and larger heads.

The direct lateral approach tothe hip was described by Hardinge in 1982. This approach provides adequateexposure of both the proximal femur and acetabulum. It has the benefit ofproviding an extensive exposure to the femur as required. A very lowdislocation rate has also been reported in clinical follow-up. However main drawback of this approach is abductor weakness as wesplit abductors of hip.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All patients with osteoarthritis, osteonecrosis, or dysplasia of hip with end stage arthritis warranting primary total hip arthroplasty in unilateral hip American Society of Anaesthesiologists (ASA) grade 1 or 2.

Exclusion Criteria

  • Patients who had previously undergone any kind of surgery in affected hip Patients undergoing revision Total Hip arthroplasty Patients with a proximal femoral deformity Patient having an active infection Patient having severe contralateral hip disease Patient having neuromuscular pathology Patient with severe bone defect or requiring structural bone grafts.

Outcomes

Primary Outcomes

2 Clinical outcome: Compare overall clinical outcomes between two group using Harris Hip Score and WOMAC score

Time Frame: At 6 weeks, 6 months, 1 year

1 radiological outcome: Compare radiological outcome by taking x-ray

Time Frame: At 6 weeks, 6 months, 1 year

3 Functional outcome: Compare the satisfactory outcome between the two groups using SF-36 score modified Forgotten Joint Score

Time Frame: At 6 weeks, 6 months, 1 year

Secondary Outcomes

  • 1 To compare peri-operative parameters like Drop of Hemoglobin, intra/immediate post-operative complication, duration of surgery(2 To compare the length of hospital stay after undergoing Total Hip Arthroplasty via two different approaches)

Investigators

Sponsor
NA
Sponsor Class
Other [n/a]

Study Sites (1)

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