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RecruitingNCT04665908Updated Apr 13, 2022

PT-led Triage for Patients With Hip o Knee Osteoarthritis

An interventional study of Assessment by PT/Orth surgeon in Knee Osteoarthritis and Hip Osteoarthritis, sponsored by Sahlgrenska University Hospital. Recruiting at 2 sites in Sweden. Per ClinicalTrials.gov, last updated 2022-04-13.

Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Oct 2020; still recruiting 5 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
478
Allocation
Randomized
Sex
All
01

Study summary

The aim of this project is to compare PT-led triage in secondary care setting for patients with hip or/and knee osteoarthritis (OA) with standard care (i.e. assessment of orthopedic surgeon). Comparison between cost-effectiveness, selection accuracy, patients perceived quality of care, quality of life and physical function will be made.

A further aim is to determine if a digital triage tool can accurately predict when a primary knee or hip referral is deemed for nonsurgical versus surgical intervention by the surgeon following the first consultation.

Read the detailed description

Osteoarthritis (OA) is a common musculoskeletal disorder and the number of people in need of surgical treatment for hip and knee OA is increasing. The waiting time for consultation with an orthopedic surgeon (OS) is long and the majority of the patient referred for assessment are not appropriate for surgical intervention. To reduce the number of patients seen by an OS and thereby shorten the waiting time, Sahlgrenska University Hospital started a Physiotherapist-led (PT-led) triage project in 2017. With PT-led triage the patients are assessed by a physiotherapist to establish the most appropriate care management; if the patient is appropriate for surgery, should be referred for continued rehabilitation, or referred back to the referring physician. To our knowledge this model of care with PT-led triage in secondary care setting have not been scientifically evaluated in Sweden.

The aim of this project is to compare PT-led triage in a secondary care setting with standard care (i.e. assessment of OS for patients with knee or /and hip OA). A further aim is to determine if a digital triage tool can accurately predict when a primary knee or hip referral is deemed for nonsurgical versus surgical intervention by the surgeon following the first consultation.

Patients referred from primary care to Sahlgrenska University hospital with primary hip and/or knee OA will be included and randomized to consultation with either PT (triage) or OS (standard practice). Data about patient reported health-related quality of life, pain, function, and patients' perception of quality of care will be collected using questionnaires at baseline, 3 and 12 months after the consultation.

Data about waiting time for consultation, proportion of patients appropriate for surgery, further investigations, and data to be able to perform cost analysis will be collected from patients´ journals, the patient administration systems, both locally and via the region Västra Götaland´s database (VEGA).

A digital triage tool will be developed and tested in a cohort of 50 patients before the ortohpedic consultation.

A qualitative approach will be used to further investigate patients experience of a PT-ledtrige

02

Conditions studied

  • Knee Osteoarthritis
  • Hip Osteoarthritis

Keywords

  • PT-led triage
  • Osteoarthritis
  • Knee
  • Hip
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 478 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Referred to Sahlgrenska University hospital
  • Primary osteoarthritis in the hip or knee
  • Understanding and speaking Swedish

Exclusion criteria

Exclusion Criteria:

  • Prior assessment by and referral from an orthopedic surgeon for the current problem
  • Secondary osteoarthritis (posttraumatic osteoarthritis, femoral head necrosis), when stated on the referral
  • Referred to a specific surgeon
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
478 participants (estimated)

Study arms

  • Other
    PT-led triage

    Patients are assessed by PT

    Other: Assessment by PT/Orth surgeon

  • Other
    Standard care

    The patiens are assessed by a orthopedic surgeon

    Other: Assessment by PT/Orth surgeon

Interventions

  • OtherAssessment by PT/Orth surgeon

    Assessment by orthopaedic surgeon or a PT

06

What researchers measure

Primary outcomes

  1. Short form of the Quality from Patients Perspective (QPP)

    A Measure of patients' perception of quality of care regarding four dimensions: caregivers' medical-technical competence; care organizations' physical-technical conditions; degree of identity-orientation in the caregivers' attitudes and actions; and the care organizations' socio-cultural atmosphere

    Time frame: Baseline

Secondary outcomes

  1. Heath-related quality of life - EuroQol (EQ5-D)

    Measure of health-related quality of life and consists of 5 items. General health is measured using a VAS scale (0 to 100) with 100 being the best possible health state

    Time frame: Baseline, 3 and 12 months

  2. Pain Disability index (PDI

    A questionnaire where respondents are asked to rate disability on a numeric rating scale ranging from 0 (no disability) to 10 (maximum disability) in seven areas; family and home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activity.

    Time frame: Baseline, 3 and 12 months

  3. Forgotten Joint Score (FJS)

    A questionnaire that was developed to find subtle differences between patients who grade their hip / knee as "very good" and "excellent". The score is graded from 0 to 100, where a high score is better

    Time frame: Basline, 3 and 12 months

  4. Oxford Hip/Knee Score (OHS/OHK

    A questionnaire consisting of 12 questions that concern areas such as pain and disabilities the patient has experienced during the past four weeks.

    Time frame: Basline, 3 and 12 months

07

Study locations

1 of 2 sites recruiting
  • Sahlgrenska University Hospital
    Gothenburg, Västra Götaland, Sweden
    • Maziar Mohaddes, DR · Contact
    Recruiting
  • Sahlgrenska University hospital
    Gothenburg, Sweden
    • Maziar Mohaddes, M.D · Contact
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04665908
Lead sponsor
Sahlgrenska University Hospital
Responsible party
Maziar Mohaddes Ardebili (MD Doctor, Sahlgrenska University Hospital) — Principal investigator
First posted
Dec 14, 2020
Start date
Oct 26, 2020
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 13, 2022

Study contacts

Maziar Mohaddes, DR
Contact
maziar.mohaddes_ardebili@vgregion.se
+46 (730) 701147
Linnéa Gustavsson, MS
Contact
+46 731575998

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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