Rehabilitation After Direct Anterior Approach for Total Hip Arthroplasty

NCT ID: NCT06356116

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-14
• Study Completion Date: 2024-12-31

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.

Conditions

Total Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual care

Patients will receive the current usual care of the post-operative physical therapy following existing procedure.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

During hospitalization, physical therapist visits the patient once or twice on day one or two post-operative (treatments including bedside standing, ambulation, stepping, active-assisted range of motion exercises).

Educational material will be given at discharge from hospital.

Accelerated rehabilitation

Patients will have pre-operative education and quicker progress rehabilitation program, and combined with telerehabilitation until 4-week post-operation.

Group Type: EXPERIMENTAL

Accelerated rehabilitation

Intervention Type: OTHER

Physical therapist visits 5 times during hospitalization, including

1. Pre-operatively: instruction regarding range of motion exercises, use of assistive device.

2. Post-operative day zero: bedside standing, ambulation, stepping, active-assisted range of motion exercises.

3. Post-operative day one: visit #1 continuing the day-zero exercises;

4. Post-operative day one: visit #2 mini-squat against wall; stair negotiation training (1/2 flight).

5. Post-operative day two: continuing the day-zero exercises; stair negotiation (1 flight); discharge from hospital in the afternoon.

After discharge from hospital: post-operative day three ~ week 4: telerehabilitation

Interventions

Usual care

During hospitalization, physical therapist visits the patient once or twice on day one or two post-operative (treatments including bedside standing, ambulation, stepping, active-assisted range of motion exercises).

Educational material will be given at discharge from hospital.

Intervention Type: OTHER

Accelerated rehabilitation

Physical therapist visits 5 times during hospitalization, including

1. Pre-operatively: instruction regarding range of motion exercises, use of assistive device.

2. Post-operative day zero: bedside standing, ambulation, stepping, active-assisted range of motion exercises.

3. Post-operative day one: visit #1 continuing the day-zero exercises;

4. Post-operative day one: visit #2 mini-squat against wall; stair negotiation training (1/2 flight).

5. Post-operative day two: continuing the day-zero exercises; stair negotiation (1 flight); discharge from hospital in the afternoon.

After discharge from hospital: post-operative day three ~ week 4: telerehabilitation

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsiu-Chen Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, Department of Physical Therapy

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hsiu-Chen Lin, PhD

Role: CONTACT

hclin@mail.cmu.edu.tw

+886422053366 ext. 7303

Facility Contacts

Hsiu-Chen Lin, PhD

Role: primary

hclin@mail.cmu.edu.tw

+886-4-22053366 ext. 7303

Other Identifiers

CMUH111-REC3-029

Identifier Type: -

Identifier Source: org_study_id