Rehabilitation After Direct Anterior Approach for Total Hip Arthroplasty

NCT06356116 | Recruiting

• 1 other identifier: CMUH111-REC3-029
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty

Keywords

direct anterior approach; total hip arthroplasty; accelerated rehabilitation; telerehabilitation

Outcome Measures

Primary Outcomes (3)

• Functional recovery questionaire

  Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) to evaluate the symptoms and functional limitations. The HOOS includes 40 items with five possible responses, graded from 0 to 4 (0 points = worst possible score; 100 points = best possible score)

  before the surgery and at 2, 4, 8, and 12 weeks after the operation

• Maximum muscle strength

  Maximum isometric contraction of the hip abductor \& flexor measured in kilogram (kg) by a hand-held dynamometer (MicroFET 2, Hoggan Scientific LLC., USA)

  before the surgery and at 2, 4, 8, and 12 weeks after the operation

• Quality of Life questionaire

  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  before the surgery and at 2, 4, 8, and 12 weeks after the operation

Secondary Outcomes (3)

• Balance function

  before the surgery and at 2, 4, 8, and 12 weeks after the operation

• Gait performance

  at 2, 4, 8, and 12 weeks after the operation

• Walking speed

  at 2, 4, 8, and 12 weeks after the operation

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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

Other: Usual care

Accelerated rehabilitation

EXPERIMENTAL

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

Other: Accelerated rehabilitation

Interventions

Usual care 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.

Usual care

Accelerated rehabilitation 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

Accelerated rehabilitation

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

Study Officials

• Hsiu-Chen Lin, PhD

  China Medical University, Department of Physical Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiu-Chen Lin, PhD

CONTACT

+886422053366; hclin@mail.cmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: April 10, 2024
• Study Start: November 14, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)