NCT06187116

Brief Summary

The overall aim with the study is to evaluate physiotherapist led triage in primary care compared to usual care (assessment by an orthopaedic surgeon in an orthopaedic department) for patients with hip or knee osteoarthritis referred for orthopaedic consultation.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Jan 2024

Longer than P75 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Jan 2024Jun 2027

First Submitted

Initial submission to the registry

May 22, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

May 22, 2023

Last Update Submit

December 15, 2023

Conditions

Keywords

PhysiotherapistOrthopaedic triageQuality of careSurgery Conversion rate

Outcome Measures

Primary Outcomes (1)

  • "I received the best possible examination and treatment (as far as I can tell)"

    One item from the questionnaire Quality from the Patients Perspective (QPP). The patients rate how they perceive the quality of care on a 4-point Likert scale ranging from 1 (do not agree at all) to 4 (completely agree). This item was chosen as main outcome since it was found the be representative of quality of care, and as it assess the desired outcome, by the subjective judgement of experts in the field (five physiotherapists and one orthopaedic surgeon).

    Within a week after assessment

Secondary Outcomes (13)

  • Quality from the Patients Perspective (QPP)

    Within a week after assessment

  • Waiting times

    12 months after the assessment

  • Management outcome incl Surgery Conversion Rate (SCR)

    12 months after the assessment

  • EuroQol 5 D (EQ-5D-5L)

    Baseline

  • EuroQol 5 D (EQ-5D-5L)

    Change from baseline to three months after assessment

  • +8 more secondary outcomes

Study Arms (2)

Physiotherapist led orthopaedic triage

EXPERIMENTAL

Patients who are randomised to PT led triage will be scheduled for a consultation with a physiotherapist (PT) at a rehabilitation clinic in primary care in the Region Västra Götaland.

Other: Physiotherapist consultation

Usual care

ACTIVE COMPARATOR

Patients who are randomised to usual care will be sceduled according to standard procedure for an orthopaedic surgeon (OS) consultation at the orthopaedic department of a hospital in the Region Västra Götaland.

Other: Orthopaedic surgeon consultation

Interventions

The consultation with the PT is 40-45 minutes long according to usual care and includes patient history, assessment and management according to an assessment template. If the patient is found not to be appropriate for surgery they can receive the following; 1) self-care without follow up appointment, 2) referral to PT in primary care for rehabilitation, 3) referral back to general practitioner (GP) for new tests/assessments/medication. If the patient is found to be appropriate for surgery, and wishes to undergo surgery, or if the PT in the study wants a second opinion, the patient is 4) referred for orthopaedic consultation for surgical consideration.

Physiotherapist led orthopaedic triage

The consultation with the OS is 20-30 minutes long and includes medical history, assessment and management plan, all according to usual care. It the patient is found not to be appropriate for surgery they can receive the following; 1) self-care without follow up appointment, 2) referral to PT in primary care for rehabilitation, 3) referral back to GP for new tests/assessments/medication. If the patient is found appropriate for surgery, and wishes to undergo surgery, the patient is 4) scheduled for surgery.

Usual care

Eligibility Criteria

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

You may qualify if:

  • primary OA in hip or knee
  • understands and speak Swedish

You may not qualify if:

  • Previously been assessed for the same condition by an orthopaedic surgeon
  • Referred by an orthopaedic surgeon
  • Secondary OA due to fractures or osteonecrosis of the femoral head
  • Referral to a specific orthopaedic surgeon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Karin S Samsson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2023

First Posted

January 2, 2024

Study Start

January 1, 2024

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2027

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication.

Time Frame
Data will become available upon reasonable request after publication of results
Access Criteria
Analyses and additional data will be available upon reasonable request