Osteoarthritis, KneeSPOSICNCT05664724
Simultaneous Physiotherapy and Orthopedic Surgeon Interdisciplinary Care (SPOSIC)
A study testing Receives interdisciplinary sessions in people with Osteoarthritis, Knee and Arthritis, run by University of British Columbia.
Trial summary
This study will test a protocol to implement simultaneous physiotherapy and orthopedic surgeon interdisciplinary care for patients undergoing knee replacement surgery. These interdisciplinary sessions will help tailor personalized goals, involving the patient as a key member of the team. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Arthritis
- What is being tested?
- Receives interdisciplinary sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Aug 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years of age or older
- Expecting to undergo knee arthroplasty surgery within 12 months
- Pain or functional limitation due to the musculoskeletal condition
- Able to walk 10 meters without physical assistance
- Able to tolerate 50 minutes of activity (including rest breaks, as needed)
- Have adequate cognitive-communicative ability to participate (based on clinical judgment of the research team)
- Able to provide informed consent
Who cannot join
- Are living in long-term care
- Have significant neurological conditions
- Are medically unstable
- Have medical condition(s) significantly impacting lower extremity function
Trial locations and contacts
No sites are listed yet.
Brodie Sakakibara, PhD contact
About this study
Official title: Simultaneous Physiotherapy and Orthopedic Surgeon Interdisciplinary Care
This study will test a protocol to implement simultaneous physiotherapy and orthopedic surgeon interdisciplinary care for patients undergoing knee replacement surgery. These interdisciplinary sessions will help tailor personalized goals, involving the patient as a key member of the team.
Read the detailed description
The purpose of this project is to test a quality improvement protocol to improve outcomes following knee arthroplasty surgery utilizing simultaneous physiotherapy and orthopedic surgeon interdisciplinary care. In an era of increasing demands on health care budgets, it is vital to improve quality of care without substantially increasing its cost. This study will focus on a quality improvement strategy that aims to redeploy existing resources to achieve higher quality care without substantially altering costs. This interdisciplinary approach involves establishing a high functioning team that includes the patient as a pivotal member and builds collaboration in the pre-operative period that can be leveraged in the post-operative period to achieve optimal outcomes. This differs from traditional, siloed care for knee arthroplasty.
Participants will be involved in usual care surrounding knee arthroplasty which includes education sessions and pre-habilitation pre-operatively and rehabilitation post-operatively. Participants will also attend two interdisciplinary sessions at 2 months and 1 month prior to surgery to outline expectations, explore patients' questions and concerns, set expectations for the next interdisciplinary session, and ensure goal congruence between all members of the team. At each of these sessions a physical assessment will also be completed by the orthopedic surgeon and physiotherapist. Following surgery, participants will attend four more interdisciplinary sessions at 2 weeks, 6 weeks, 3 months, and 6 months post-operatively. These sessions will address safety and medical issues, revisit patient expectations, reinforce care team expectations, focus on a personalized rehabilitation plan, and ensure goal congruence between the various team members. The physical assessment will also be repeated.
The objectives of the study are as follows:
- Evaluate the feasibility (e.g., recruitment and retention, administrative and participant burden, lived experiences) of treating knee arthroplasty patients through a novel interdisciplinary program aimed to optimize recovery among patients; and
- Estimate the size of the program's effect on biopsychosocial outcomes among community-dwelling individuals undergoing knee arthroplasty and rehabilitation.
The hypotheses of the study are as follows:
- The protocol will establish proof-of-concept, and demonstrate sufficient feasibility to support a future full-scale multi-site RCT.
- Simultaneous physiotherapy and orthopedic surgery interdisciplinary care (SPOSIC) will improve the primary outcome of functional disability, as measured by the 12-item Oxford Knee score (OKS), and improvements will also be shown in the secondary outcomes of pain, participation in social roles, health-related quality of life, and mobility.
- Conditions
- Osteoarthritis, Knee, Arthritis
- Being tested
- Receives interdisciplinary sessions
- Keywords
- arthroplasty, rehabilitation, interdisciplinary
- Medical subject headings
- Osteoarthritis, Knee, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receives interdisciplinary sessionsBehavioural
Along with usual care, participants receive six interdisciplinary sessions at 2 months and 1 month pre-operatively and 2 weeks, 6 weeks, 3 months, and 6 months post-operatively attended by an orthopedic surgeon, a physiotherapist, a patient navigator, and the patient. The pre-operative interdisciplinary sessions will outline expectations, explore patients' questions and concerns, set expectations for the next interdisciplinary session, and ensure goal congruence between all members of the team.
Along with usual care during the post-operative period, participants will receive interdisciplinary sessions that address safety and medical issues, revisit patient expectations, reinforce care team expectations, focus on a personalized rehabilitation plan, and ensure goal congruence between the various team members.
| Study group | Role | What they receive |
|---|---|---|
| Receives interdisciplinary sessions | Experimental | Interdisciplinary care by a team that includes: orthopedic surgeon, physiotherapist, a patient navigator, and the patient Receives: Behavioral: Receives interdisciplinary sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxford Knee Score Questionnaire
Subjectively measures functional ability. Minimum score: 0. Maximum score: 48. Higher score indicates better outcome.
Measured: Baseline, Post-intervention (immediately after 6 month post-op intervention)
Secondary outcomes (6)
Change in Pain Visual Analogue Scale
Subjective measurement of pain. Minimum score: 0cm. Maximum score: 10cm. Lower score indicates better outcome.
Measured: Baseline, Post-intervention (immediately after 6 month post-op intervention)
Change in Keele Assessment of Participation Questionnaire
Subjective measurement of social role participation restrictions. Minimum score: 0. Maximum score: 44. Higher score indicates better outcome.
Measured: Baseline, Post-intervention (immediately after 6 month post-op intervention)
Change in EuroQol 5D3L Questionnaire
Subjective measurement of health-related quality of life. Minimum score: 0.0. Maximum score: 1.0. Higher score indicates better outcome.
Measured: Baseline, Post-intervention (immediately after 6 month post-op intervention)
Change in Timed Up and Go Test
Objectively measures mobility. Minimum score: 0s. Maximum score: unlimited s. A lower score indicates a better outcome.
Measured: Baseline, Post-intervention (immediately after 6 month post-op intervention)
Satisfaction Survey
Measures participants' satisfaction or dissatisfaction with the intervention. Scores ranked from strongly disagree to strongly agree. Strongly agree indicates a participant was more satisfied with the intervention.
Measured: Post-intervention (immediately after 6 month post-op intervention)
Semi-structured interview
Open-ended questions regarding participants' attitudes and satisfaction with the program and areas for improvement
Measured: Post-intervention (immediately after 6 month post-op intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study startFeb 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Interior Health
- Responsible party
- Principal investigator, Brodie Sakakibara, University of British Columbia
- Investigators
- Brodie Sakakibara, PhD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664724
- Sponsor's protocol ID
- SPOSIC
- Acronym
- SPOSIC
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 27 Dec 2022
- 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 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Physiotherapy and Orthopedic Surgeon Interdisciplinary Care
- ClinicalTrials.gov ID
- NCT05664724
- Acronym / sponsor ID
- SPOSIC / SPOSIC
- Conditions
- Osteoarthritis, Knee, Arthritis
- Keywords
- arthroplasty, rehabilitation, interdisciplinary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Interior Health
- Study start
- Feb 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 27 Dec 2022 (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.
This study will test a protocol to implement simultaneous physiotherapy and orthopedic surgeon interdisciplinary care for patients undergoing knee replacement surgery. These interdisciplinary sessions will help tailor personalized goals, involving the patient as a key member of the team.
Detailed description
The purpose of this project is to test a quality improvement protocol to improve outcomes following knee arthroplasty surgery utilizing simultaneous physiotherapy and orthopedic surgeon interdisciplinary care. In an era of increasing demands on health care budgets, it is vital to improve quality of care without substantially increasing its cost. This study will focus on a quality improvement strategy that aims to redeploy existing resources to achieve higher quality care without substantially altering costs. This interdisciplinary approach involves establishing a high functioning team that includes the patient as a pivotal member and builds collaboration in the pre-operative period that can be leveraged in the post-operative period to achieve optimal outcomes. This differs from traditional, siloed care for knee arthroplasty.
Participants will be involved in usual care surrounding knee arthroplasty which includes education sessions and pre-habilitation pre-operatively and rehabilitation post-operatively. Participants will also attend two interdisciplinary sessions at 2 months and 1 month prior to surgery to outline expectations, explore patients' questions and concerns, set expectations for the next interdisciplinary session, and ensure goal congruence between all members of the team. At each of these sessions a physical assessment will also be completed by the orthopedic surgeon and physiotherapist. Following surgery, participants will attend four more interdisciplinary sessions at 2 weeks, 6 weeks, 3 months, and 6 months post-operatively. These sessions will address safety and medical issues, revisit patient expectations, reinforce care team expectations, focus on a personalized rehabilitation plan, and ensure goal congruence between the various team members. The physical assessment will also be repeated.
The objectives of the study are as follows:
- Evaluate the feasibility (e.g., recruitment and retention, administrative and participant burden, lived experiences) of treating knee arthroplasty patients through a novel interdisciplinary program aimed to optimize recovery among patients; and
- Estimate the size of the program's effect on biopsychosocial outcomes among community-dwelling individuals undergoing knee arthroplasty and rehabilitation.
The hypotheses of the study are as follows:
- The protocol will establish proof-of-concept, and demonstrate sufficient feasibility to support a future full-scale multi-site RCT.
- Simultaneous physiotherapy and orthopedic surgery interdisciplinary care (SPOSIC) will improve the primary outcome of functional disability, as measured by the 12-item Oxford Knee score (OKS), and improvements will also be shown in the secondary outcomes of pain, participation in social roles, health-related quality of life, and mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receives interdisciplinary sessions | Experimental | Behavioral: Receives interdisciplinary sessionsInterdisciplinary care by a team that includes: orthopedic surgeon, physiotherapist, a patient navigator, and the patient |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 19 years of age or older
- Expecting to undergo knee arthroplasty surgery within 12 months
- Pain or functional limitation due to the musculoskeletal condition
- Able to walk 10 meters without physical assistance
- Able to tolerate 50 minutes of activity (including rest breaks, as needed)
Key exclusion criteria (4 listed)
- Are living in long-term care
- Have significant neurological conditions
- Are medically unstable
- Have medical condition(s) significantly impacting lower extremity function
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 |
|---|---|---|
| Receives interdisciplinary sessionsAlong with usual care, participants receive six interdisciplinary sessions at 2 months and 1 month pre-operatively and 2 weeks, 6 weeks, 3 months, and 6 months post-operatively attended by an orthopedic surgeon, a physiotherapist, a patient navigator, and the patient. The pre-operative interdisciplinary sessions will outline expectations, explore patients' questions and concerns, set expectations for the next interdisciplinary session, and ensure goal congruence between all members of the team. Along with usual care during the post-operative period, participants will receive interdisciplinary sessions that address safety and medical issues, revisit patient expectations, reinforce care team expectations, focus on a personalized rehabilitation plan, and ensure goal congruence between the various team members. | Behavioural | Receives interdisciplinary sessions |
Primary outcome
Change in Oxford Knee Score Questionnaire
Time frame: Baseline, Post-intervention (immediately after 6 month post-op intervention)
Subjectively measures functional ability. Minimum score: 0. Maximum score: 48. Higher score indicates better outcome.
6 secondary outcomes
Change in Pain Visual Analogue Scale
Time frame: Baseline, Post-intervention (immediately after 6 month post-op intervention)
Change in Keele Assessment of Participation Questionnaire
Time frame: Baseline, Post-intervention (immediately after 6 month post-op intervention)
Change in EuroQol 5D3L Questionnaire
Time frame: Baseline, Post-intervention (immediately after 6 month post-op intervention)
Change in Timed Up and Go Test
Time frame: Baseline, Post-intervention (immediately after 6 month post-op intervention)
Satisfaction Survey
Time frame: Post-intervention (immediately after 6 month post-op intervention)
Semi-structured interview
Time frame: Post-intervention (immediately after 6 month post-op intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- 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.
Brodie Sakakibara, PhD contact
Brodie Sakakibara, PhD principal investigator
The University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Receives interdisciplinary sessions in people with Osteoarthritis, Knee and Arthritis, run by University of British Columbia.
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 7 inclusion and 4 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 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Holly Wise (250.558-9140, holly.wise@interiorhealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxford Knee Score Questionnaire (time frame: Baseline, Post-intervention (immediately after 6 month post-op intervention)). 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 27 Dec 2022.