Total Hip ArthroplastyNCT06356116
Rehabilitation After Direct Anterior Approach for Total Hip Arthroplasty
A study testing Accelerated rehabilitation in people with Total Hip Arthroplasty, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Accelerated rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Nov 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who will undergo the DAA for total hip replacement due to osteoarthritis or avascular necrosis of the femoral head
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Hsiu-Chen Lin, PhD, +886-4-22053366 ext. 7303, hclin@mail.cmu.edu.tw
About this study
Official title: Accelerated Rehabilitation Program and Functional Recovery After Direct Anterior Approach for Total Hip Arthroplasty
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.
Read the 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
- Being tested
- Usual care, Accelerated rehabilitation
- Keywords
- direct anterior approach, total hip arthroplasty, accelerated rehabilitation, telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
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 rehabilitationOther
Physical therapist visits 5 times during hospitalization, including
- Pre-operatively: instruction regarding range of motion exercises, use of assistive device.
- Post-operative day zero: bedside standing, ambulation, stepping, active-assisted range of motion exercises.
- Post-operative day one: visit #1 continuing the day-zero exercises;
- Post-operative day one: visit #2 mini-squat against wall; stair negotiation training (1/2 flight).
- 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
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Patients will receive the current usual care of the post-operative physical therapy following existing procedure. Receives: 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. Receives: Other: Accelerated rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: before the surgery and at 2, 4, 8, and 12 weeks after the operation
Secondary outcomes (3)
Balance function
Biodex Balance System, Biodex Corp., USA
Measured: before the surgery and at 2, 4, 8, and 12 weeks after the operation
Gait performance
Seven wireless sensors (RehaGait Basic) strapped on the waist and the lower extremities, and then walk with comfortable speed on a 10-meter walkway, forth and back. The bilateral symmetry (%) in hip flexion angle will be calculated.
Measured: at 2, 4, 8, and 12 weeks after the operation
Walking speed
Seven wireless sensors (RehaGait Basic) strapped on the waist and the lower extremities, and then walk with comfortable speed on a 10-meter walkway, forth and back. The walking speed (m/s) will be calculated.
Measured: at 2, 4, 8, and 12 weeks after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start14 Nov 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiu-Chen Lin, PhD, Principal investigator, China Medical University, Department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356116
- Sponsor's protocol ID
- CMUH111-REC3-029
- Status last verified
- Apr 2024
- First submitted
- 16 Feb 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Rehabilitation Program and Functional Recovery After Direct Anterior Approach for Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06356116
- Acronym / sponsor ID
- CMUH111-REC3-029
- Conditions
- Total Hip Arthroplasty
- Keywords
- direct anterior approach, total hip arthroplasty, accelerated rehabilitation, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual carePatients will receive the current usual care of the post-operative physical therapy following existing procedure. |
| Accelerated rehabilitation | Experimental | Other: Accelerated rehabilitationPatients will have pre-operative education and quicker progress rehabilitation program, and combined with telerehabilitation until 4-week post-operation. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who will undergo the DAA for total hip replacement due to osteoarthritis or avascular necrosis of the femoral head
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careDuring 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. | Other | Usual care |
| Accelerated rehabilitationPhysical 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 | Other | Accelerated rehabilitation |
Primary outcome
Functional recovery questionaire
Time frame: before the surgery and at 2, 4, 8, and 12 weeks after the operation
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)
Maximum muscle strength
Time frame: before the surgery and at 2, 4, 8, and 12 weeks after the operation
Maximum isometric contraction of the hip abductor \& flexor measured in kilogram (kg) by a hand-held dynamometer (MicroFET 2, Hoggan Scientific LLC., USA)
Quality of Life questionaire
Time frame: before the surgery and at 2, 4, 8, and 12 weeks after the operation
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.
3 secondary outcomes
Balance function
Time frame: before the surgery and at 2, 4, 8, and 12 weeks after the operation
Gait performance
Time frame: at 2, 4, 8, and 12 weeks after the operation
Walking speed
Time frame: at 2, 4, 8, and 12 weeks after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiu-Chen Lin, PhD principal investigator
China Medical University, Department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated rehabilitation in people with Total Hip Arthroplasty, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsiu-Chen Lin, PhD (+886422053366 ext. 7303, hclin@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional recovery questionaire (time frame: before the surgery and at 2, 4, 8, and 12 weeks after the operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.