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Osteoarthritis, KneeNCT06459960

Effect of Hydrotherapy After Unilateral UKA

A study testing Hydrotherapy and Convention in people with Osteoarthritis, Knee, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Osteoarthritis (OA) is a progressive disease of the synovial joints that causes joint pain and limitation of function resulting in considerable morbidity and impairment of quality of life. Knee OA is the most common type of OA, and symptomatic knee OA is highly prevalent among people aged over 50 years. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Hydrotherapy and Convention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteHong Kong
Study dates
15 Dec 2020to 15 Dec 2021
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who aged 18 or above, and underwent primary unilateral UKA , with the Oxford model, at the Department of Orthopaedics and Traumatology of the Alice Ho Miu Ling Nethersole Hospital (AHNH) in year 2018 and 2019 were included.

Who cannot join

  • Patients who had post operative complications, underwent revision or robotic assisted surgery or bilateral knee arthro plasty, defaulted follow up, received post operative physiotherapy rehabilitation which was not at the Physiotherapy Department of AHNH, had cognitive impairment, or were unsuitable for exercise training, were excluded in this study.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Alice Ho Miu Ling Nethersole Hospital

    Tai Po, N.T.

Other trials in Hong Kong

About this study

Official title: Effect of a Tailor-made Hydrotherapy on Physical Functions in Patients After Unilateral Unicompartmental Knee Arthroplasty

Osteoarthritis (OA) is a progressive disease of the synovial joints that causes joint pain and limitation of function resulting in considerable morbidity and impairment of quality of life. Knee OA is the most common type of OA, and symptomatic knee OA is highly prevalent among people aged over 50 years. With the increasing aging population, worldwide prevalence of knee OA is expected to be rising. The goals of treatment are to reduce pain, maintain or improve joint mobility, minimize functional impairment and improve quality of life. When conservative management, which includes structured land-based exercise programs, aquatic exercise, education and appropriate analgesic medications, fails, surgical approach can be considered. Unicompartmental knee arthroplasty (UKA) has become an alternative to TKA in cases of end-stage OA that are limited to a single compartment. Patients who underwent UKA have a quicker recovery, lower risk of complications, and improved range of motion. Physiotherapy rehabilitation is an integral part of good knee arthroplasty outcome. Conventional post-operative physiotherapy rehabilitation, which includes range of motion exercises, muscle strengthening exercises, balance and gait training, have been shown to have improvement in range of motion, muscle strength and functional outcome measures of patients. Recently, hydrotherapy is gaining its popularity as being incorporated into one of the components in the rehabilitation after knee arthroplasty. Studies reported that hydrotherapy could decrease pain, and improved physical function, strength and quality of life for patients after total hip or knee arthroplasty. However, there are no studies to investigate the effect of hydrotherapy on patients after UKA. With the increasing popularity of UKA as a surgical alternative in patients with end-stage single-compartmental OA, it is worth investigating the effects of hydrotherapy on the clinical outcomes of patients following UKA.

Read the detailed description

Osteoarthritis (OA) of the knee is one of the most common chronic degenerative joint diseases, primarily affecting the ageing population, limiting joint movement and causing disability because of pain and stiffness. Prevalence of radiologic knee OA increased in proportion to age, reaching 64.1% for those who were aged 60 and over, and had a higher prevalence in females than males. OA is a progressive joint disorder, characterized by progressive softening and disintegration of articular cartilage, growth of osteophytes and fibrosis of joint capsule. Clinical presentations vary from asymptomatic despite the presence of radiological evidence, to progressively evolving symptoms and eventually severely disabling joints. Knee OA is the most common type of OA, affecting patello-femoral joint and/or medial tibio- femoral joint. Symptoms of knee OA include joint pain, knee effusion, quadriceps muscle weakness and wasting, giving way, and knee deformities such as fixed flexion contractures and varus knees. These can lead to functional limitations, resulting in substantial morbidity and impaired quality of life. The Global Burden of Diseases studies reported that OA was the leading cause of lower extremity disability in elderly, with hip and knee OA accounting for 1.12% of years lived with disability. OA has been reported to be ranked the seventh leading cause of global years lived with disability. Moreover, knee OA leads to substantial medical expenses and economic burden. Patients suffering from knee OA flock to general practitioners and orthopaedic specialists for analgesic medications and injections, or physiotherapists for exercise consultations, or orthopaedic surgeons for surgery. These reactions subsequently become burden to healthcare systems and expenses leading to healthcare dilemmas.

The ever-aging population proved to be one of the strongest predictors of OA, particularly in patients with age 50 years and higher. Studies reported that there was a high prevalence of symptomatic knee OA among people aged over 50 years, affecting more than 250 million people worldwide. With the growing aging population, worldwide prevalence of knee OA is expected to be rising. Therefore, knee OA is gaining attention from our society, policy makers and medical professionals on its management, aiming at holistic, cost-effective and evidence-based care approach. Management of knee OA can be classified into conservative and surgical approaches, aiming at reducing pain, maintaining or improving joint mobility, minimizing functional impairment and improving quality of life. For conservative approach, a combination of non-pharmacological and pharmacological modalities, which include structured land-based exercise programs, aquatic exercise, education and appropriate analgesic medications, are recommended and supported by evidence.

Surgery is the subsequent approach after failure in conservative management. Total knee arthroplasty (TKA) has been the dominating surgery for patients who suffer from severe end- stage symptomatic OA but fail to respond to conservative management and have significantly impaired function and quality of life. Recently, unicompartmental knee arthroplasty (UKA) has become an alternative to TKA for patients with end-stage knee OA.

Patients after UKA reported quicker recovery period, lower risk of complications and better range of motion if the knee. Our group investigated the correlation between femoral and tibial component axial rotational alignment and functional outcomes in 83 Oxford UKA from in 67 patients with isolated medial or lateral compartment knee osteoarthritis. We found that femoral component axial rotation between 2° and 6° external rotation, and tibial component axial rotation between 1° and 8° external rotation correlated with significantly better functional scores, with the highest functional scores observed at 3°-4° external rotation for femoral component, and 4°-5° external rotation for tibial component.

After knee arthroplasty, physiotherapy rehabilitation is a part of non-invasive treatments leading to a successful outcome after surgery. Conventional post-operative physiotherapy, including exercises aiming at improving range of motion, muscle strengthening, body balance and gait training, showed to have improvement in range of motion and muscle strength of knee. An European review on exercises after knee arthroplasty reported improvements in various functional outcome measures such as Western Ontario and McMaster Universities Arthritis Index (WOMAC), Medical Outcome Study Short Form-36 (SF-36), Oxford Knee Score, American Knee Society Score, Lower Extremity Functional Scale and Iowa Lower Extremity Scale.

Recently, hydrotherapy is gaining popularity on its use being an important component in rehabilitation programme after knee arthroplasty. Hydrotherapy is the external or internal use of water in any of its forms (water (liquid), ice (solid), steam (gas)) for health promotion or treatment of various diseases with various temperatures, pressure, duration, and site. In clinical settings, patients exercise in a temperature-controlled water pool led by a physiotherapist. Exercising in water has a long history of beneficial therapeutic effect to promote healing in certain medical conditions. Hydrotherapy has been widely used in various musculoskeletal and neurologic conditions, from paediatric to geriatric population. Patients exercising in a hydrotherapy pool could perform better than on land and let patients who could not perform the same exercise on land work out under water. Benefits of warm-bathing hydrotherapy include relieving pain and muscle spasm through warmth, reducing loading of joints through buoyancy, decreasing oedema through pressure from immersion, and producing resistance to movement through turbulence and hydrostatic pressure. Studies proved that hydrotherapy could decrease pain, and improve physical functions, muscle strength and quality of life in patients after total hip or knee arthroplasty.

Given the benefits of hydrotherapy on patients who underwent joint replacement, there is no study investigating the effect of hydrotherapy on patients after UKA. With the increasing popularity of UKA as a surgical alternative to TKA for patients with end stage single-compartmental knee OA, it is worth investigating the effects of hydrotherapy on the clinical outcomes of patients following UKA. Results can guide further discussions on whether hydrotherapy should be incorporated into the post-joint replacement surgery physiotherapy rehabilitation in clinical practice.

Being tested
Hydrotherapy, Convention
Keywords
unicompartmental knee arthroplasty, hydrotherapy, physical function
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydrotherapyGenetic

    Heated pool (32°C); Convention rehabilitation + Hydrotherapy

  • ConventionGenetic

    Convention rehabilitation only

Study groups in NCT06459960
Study groupRoleWhat they receive
HydrotherapyExperimentalPatients practised the rehabilitation exercises in a heated pool (32°C). Exercises included: 1) Knee mobilization exercises, 2) Muscle stretching exercises, 3) Muscle strengthening exercises, such as wall slide, leg press with life ring, and lunges, 4) Balance and functional training - Single-leg standing, tandem walking, heel walking and tip-toe walking, and 5) Balance functional training - Cycling in water, fast walking and running (for patients in Hydrotherapy group only). Patients practised once a week for a total of four weeks, complimentary to conventional physiotherapy rehabilitation (8 weeks). Total number of weeks is 8+4 weeks = 12 weeks.
Receives: Genetic: Hydrotherapy
ConventionActive comparatorThe conventional physiotherapy rehabilitation programme included: 1) knee mobilization exercises, such as static bike and heel sliding board, 2) Muscle stretching exercises of hamstrings and calf, 3) Muscle strengthening exercises, such as adding cuff weights for quadriceps strengthening and wall slide with gym ball, and 4) Balance and functional training, such as stepping or single-leg standing on soft foam, stepping exercises on various heights of steps. Patients practised twice a week for a total of 8 weeks.
Receives: Genetic: Convention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knee Society Function Score (KFS)

    KFS is widely adopted as an outcome measure in knee arthroplasty related research. KFS assesses the patient's walking distance, stairs performance and the use of walking aid. The full mark is 100, with higher marks indicating better knee function and vice versa

    Measured: Baseline (Before surgery), Post-op 6 months, Post-op 1 year

Secondary outcomes (5)
  1. Self-reported walking tolerance (minutes)

    Self-reported walking tolerance is a self-reported walking tolerance test to test the maximum time (in minutes) to tolerate walking before taking a rest.

    Measured: Post-op first session and Post-op last session of rehabilitation programme; 12 weeks apart for Hydrotherapy group and 8 weeks apart for Convention group.

  2. Timed Up and Go Test (TUGT) (seconds)

    TUGT measures the time required for the patient to rise from an armchair under standardized seat height, follow by walking for three meters, then return to sitting on the same chair.

    Measured: Post-op first session and Post-op last session of rehabilitation programme; 12 weeks apart for Hydrotherapy group and 8 weeks apart for Convention group.

  3. 30-second Chair Stand Test (30CST) (repetitions)

    30CST measures the number of cycles or repetitions of continuous standing up and sitting down from a designated chair in 30 seconds. The test begins with the subject seated. The subject is then asked to rise from chair with arms folded across chest after command at the preferred speed.

    Measured: Post-op first session and Post-op last session of rehabilitation programme; 12 weeks apart for Hydrotherapy group and 8 weeks apart for Convention group.

  4. Numeric pain rating scale (NPRS)

    NPRS has been routinely applied to let patients rate the pain level on a defined scale. NPRS is a single 11-point numeric scale ranging between 0 and 10, with 0 representing "no pain" and 10 representing the pain extreme.

    Measured: Post-op first session, Post-op 4 weeks, and 3) Post-op last session of rehabilitation programme; 12 weeks apart for Hydrotherapy group and 8 weeks apart for Convention group

  5. Passive range of motion - Flexion and Extension

    Passive ROM is the ability of a joint to be moved through its normal arc of motion while relaxed and the motion was performed by an outside force, for example, the therapist's hand, the client's opposite hand, or gravity. Passive ROM allows the assessor to focus on the quality of the joint structure and ligaments.

    Measured: Post-op first session, Post-op 4 weeks, and 3) Post-op last session of rehabilitation programme; 12 weeks apart for Hydrotherapy group and 8 weeks apart for Convention group.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2024
  2. Study start15 Dec 2020
  3. Primary completion15 Dec 2021
  4. Study completion15 Dec 2021

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients were divided into 1) hydrotherapy group (Hydrotherapy) or 2) convention group (Convention)
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06459960
Sponsor's protocol ID
2020.586
Status last verified
Jun 2024
First submitted
11 Jun 2024
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Share among Study PI and research assistants within the facility only.

Publications

  • Chau WW, Lau MY, Choi TL, Lam GY, Ong MT, Ho KK. Effect of a tailor-made hydrotherapy on physical functions in patients after unilateral unicompartmental knee arthroplasty-A feasibility study. Arthroplasty. 2025 Feb 5;7(1):9. doi: 10.1186/s42836-024-00291-x.

    PubMed 39905574

Questions about this trial

What is this clinical trial studying?

A study testing Hydrotherapy and Convention in people with Osteoarthritis, Knee, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 1 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: finished, as of the sponsor's last update on 14 Jun 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 Hong Kong. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Society Function Score (KFS) (time frame: Baseline (Before surgery), Post-op 6 months, Post-op 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06459960, which also lists 1 linked publication.

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 14 Jun 2024.

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