NCT06270446

Brief Summary

To investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable knee-osteoarthritis

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

January 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

February 14, 2024

Last Update Submit

February 14, 2024

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • TUG

    TUG score

    3 months

  • 30 sec chair stand test

    30 sec chair stand test score

    3 months

  • Pain intensity

    Pain intensity score

    3 months

Secondary Outcomes (3)

  • Knee flexion and extension

    3 months

  • Passive range of motion

    3 months

  • Presence of lag

    3 months

Other Outcomes (1)

  • OKS

    3 months

Study Arms (2)

Outpatient

OTHER

Usual care, outpatient physiotherapy

Other: Outpatient physiotherapy

CRC

ACTIVE COMPARATOR

Community based physiotherapy

Other: Community based physiotherapy

Interventions

Community based physiotherapyOTHER

Physiotherapy at community rehabilitation center

CRC
Outpatient physiotherapyOTHER

Physiotherapy at hospital

Outpatient

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • i) unilateral TKA; ii) age 55 years old and above; iii) able to engage in outpatient physiotherapy; iii) postoperative knee flexion ≥75° and knee extension ≤5°; iv) able to ambulate independently preoperatively.

You may not qualify if:

  • i) had revision TKA or fully constrained knee arthroplasty; ii) had knee replacement for indications other than osteoarthritis; iii) had post-operative complications during hospital stay; iv) were unable to participate due to cognitive impairment or language barriers; v) had acute spinal diseases or joint, muscle or systemic diseases affecting gait; iv) had comorbid health conditions that would prevent active participation (e.g. prior hemiplegic stroke, severe cardiorespiratory illnesses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Eng Chuan Neoh

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Data analysis blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 21, 2024

Study Start

January 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations

SG(1)