NCT06459960

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 11, 2024

Last Update Submit

June 13, 2024

Conditions

Keywords

unicompartmental knee arthroplastyhydrotherapyphysical function

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (5)

  • Self-reported walking tolerance (minutes)

    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.

  • Timed Up and Go Test (TUGT) (seconds)

    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.

  • 30-second Chair Stand Test (30CST) (repetitions)

    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.

  • Numeric pain rating scale (NPRS)

    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

  • Passive range of motion - Flexion and Extension

    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.

Study Arms (2)

Hydrotherapy

EXPERIMENTAL

Patients 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.

Genetic: Hydrotherapy

Convention

ACTIVE COMPARATOR

The 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.

Genetic: Convention

Interventions

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

Hydrotherapy
ConventionGENETIC

Convention rehabilitation only

Convention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alice Ho Miu Ling Nethersole Hospital

Tai Po, N.T., Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

HydrotherapyCongresses as Topic

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitationOrganizationsHealth Care Economics and Organizations

Study Officials

  • Kevin Ki-Wai Ho, FRCSEDOrtho

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients were divided into 1) hydrotherapy group (Hydrotherapy) or 2) convention group (Convention)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professional Consultant

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

December 15, 2020

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Share among Study PI and research assistants within the facility only.

Locations