Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05664724 |
| Other study ID # |
SPOSIC |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2023 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
December 2022 |
| Source |
University of British Columbia |
| Contact |
Holly Wise |
| Phone |
250.558-9140 |
| Email |
holly.wise[@]interiorhealth.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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:
1. 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
2. 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:
1. The protocol will establish proof-of-concept, and demonstrate sufficient feasibility to
support a future full-scale multi-site RCT.
2. 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.
