Clinical trial NCT06356116: Rehabilitation After Direct Anterior Approach for Total Hip Arthroplasty
Official title: Accelerated Rehabilitation Program and Functional Recovery After Direct Anterior Approach for Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: direct anterior approach
total hip arthroplasty
accelerated rehabilitation
telerehabilitation
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The causes for total hip arthroplasty (THA) in Taiwan include ischemic necrosis of the femoral head and degenerative osteoarthritis. Contemporary, the surgical approach for total hip replacement mostly adopts the lateral approach. However, the direct anterior approach (DAA) has gained attention gradually due to its characteristics such as muscle preservation, small surgical incision length, and few surgical complications. Nevertheless, literature lacks detailed exploration or long-term follow-up on the recovery of physical functions related to fall occurrence after this type of surgery. It limits the establishment and design of suitable post-operative rehabilitation plans. Therefore, this study aims to explore and follow-up the functional recovery in patients who undergo the DAA for hip replacement using current usual care and new-designed accelerated rehabilitation program. The proposed method involves recruiting 30 patients who will undergo the DAA for total hip replacement, who will receive the current usual care plan; and another 30 patients will receive the accelerated rehabilitation program. The assessments will be conducted before the surgery and at 2, 4, 8, and 12 weeks after the operation, evaluating hip joint function, hip abduction and flexion muscle strength, balance function, and gait performance. The statistical analysis will utilize mixed-model two-factor ANOVA, comparing the preoperative and postoperative recovery of patients undergoing the DAA with different intervention programs and at different time points. The expected outcome of this study is to enhance the understanding of the functional recovery of patients undergoing the DAA for total hip replacement in terms of hip joint function, muscle strength, balance function, and gait performance after surgery. This information will help establish the targeted DAA postoperative treatment plans, which will be practically applied to patients and compared with the current usual care to assess its effectiveness, ultimately contributing to more efficient rehabilitation plans in the future.

Detailed description: The causes for total hip arthroplasty (THA) in Taiwan include ischemic necrosis of the femoral head and degenerative osteoarthritis. Although patients experience significant improvements in pain relief, quality of life, and physical function after the procedure, the long-term follow-up studies have found residual deficits in hip abductor muscle strength, balance function, and gait, which may result in a fear of falling or related issues. Contemporary, the surgical approach for total hip replacement mostly adopts the lateral approach. However, the direct anterior approach (DAA) has gained attention gradually due to its characteristics such as muscle preservation, small surgical incision length, and few surgical complications. Nevertheless, literature lacks detailed exploration or long-term follow-up on the recovery of physical functions related to fall occurrence, such as muscle strength and gait deviations, after this type of surgery. It limits the establishment and design of suitable post-operative rehabilitation plans. Therefore, this study aims to explore and follow-up the functional recovery in patients who undergo the DAA for hip replacement using current usual care and new-designed accelerated rehabilitation program. This study will explore the recovery in muscle strength, balance function, and gait performance of the patients before and at different postoperative time points, and also compare the differences between two groups who receive different rehabilitation programs. The proposed method involves recruiting 30 patients who will undergo the DAA for total hip replacement, who will receive the current usual care plan; and another 30 patients will receive the accelerated rehabilitation program. The assessments will be conducted before the surgery and at 2, 4, 8, and 12 weeks after the operation, evaluating hip joint function, hip abduction and flexion muscle strength, balance function, and gait performance. The statistical analysis will utilize mixed-model two-factor ANOVA, comparing the preoperative and postoperative recovery of patients undergoing the DAA with different intervention programs and at different time points. The expected outcome of this study is to enhance the understanding of the functional recovery of patients undergoing the DAA for total hip replacement in terms of hip joint function, muscle strength, balance function, and gait performance after surgery. This information will help establish the targeted DAA postoperative treatment plans, which will be practically applied to patients and compared with the current usual care to assess its effectiveness, ultimately contributing to more efficient rehabilitation plans in the future.

Eligibility criteria: Inclusion Criteria:

* patients who will undergo the DAA for total hip replacement due to osteoarthritis or avascular necrosis of the femoral head

Exclusion Criteria:

* no other surgery in the lower extremity in the recent year
* no auto-immune or other systemic disease that affected the ambulation ability
* can not walk independently over 10 meter due to other reason before this surgery

Primary outcomes:
measure: Functional recovery questionaire
timeFrame: before the surgery and at 2, 4, 8, and 12 weeks after the operation
measure: Maximum muscle strength
timeFrame: before the surgery and at 2, 4, 8, and 12 weeks after the operation
measure: Quality of Life questionaire
timeFrame: before the surgery and at 2, 4, 8, and 12 weeks after the operation
Secondary outcomes:
measure: Balance function
timeFrame: before the surgery and at 2, 4, 8, and 12 weeks after the operation
measure: Gait performance
timeFrame: at 2, 4, 8, and 12 weeks after the operation
measure: Walking speed
timeFrame: at 2, 4, 8, and 12 weeks after the operation
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University, Department of Physical Therapy
name: Hsiu-Chen Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: