Knee OsteoarthritisNCT04665908
PT-led Triage for Patients With Hip o Knee Osteoarthritis
A study testing Assessment by PT/Orth surgeon in people with Knee Osteoarthritis and Hip Osteoarthritis, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis
- What is being tested?
- Assessment by PT/Orth surgeon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 675 participants
- Where
- 2 sitesSweden
- Study dates
- 26 Oct 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Referred to Sahlgrenska University hospital
- Primary osteoarthritis in the hip or knee
- Understanding and speaking Swedish
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County
Sahlgrenska University hospital
Gothenburg
About this study
Official title: PT-led Triage in Secondary Care Settings for Patients With Hip or/and Knee Osteoarthritis
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 explore patients expectations and experiences of PT-led triage in a secondary care setting.
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 qualitative approach will be used to further investigate patients expectations and experience of a PT-led trige.
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Being tested
- Assessment by PT/Orth surgeon
- Keywords
- PT-led triage, Osteoarthritis, Knee, Hip
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment by PT/Orth surgeonOther
Assessment by orthopaedic surgeon or a PT
| Study group | Role | What they receive |
|---|---|---|
| PT-led triage | Other | Patients are assessed by PT Receives: Other: Assessment by PT/Orth surgeon |
| Standard care | Other | The patiens are assessed by a orthopedic surgeon Receives: Other: Assessment by PT/Orth surgeon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (4)
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
Measured: Baseline, 3 and 12 months
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.
Measured: Baseline, 3 and 12 months
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
Measured: Basline, 3 and 12 months
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.
Measured: Basline, 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start26 Oct 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maziar Mohaddes Ardebili, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665908
- Sponsor's protocol ID
- Triage and hip/knee OA
- Status last verified
- May 2025
- First submitted
- 7 Dec 2020
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gustavsson L, Broman D, Beischer S, Samsson K. In safe hands - patients with knee and hip osteoarthritis expectations and experience of physical therapist-led triage in a secondary care setting. BMC Musculoskelet Disord. 2026 Jul 7;27(1):584. doi: 10.1186/s12891-026-10179-3.
PubMed 42414961Gustavsson L, Mohaddes M, Samsson K, Beischer S. No major difference in perceived quality of care in patients with hip or knee osteoarthritis assessed in a physical therapy-led triage compared with standard care: a randomized controlled trial. BMC Musculoskelet Disord. 2023 Jun 29;24(1):530. doi: 10.1186/s12891-023-06659-5.
PubMed 37386368
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PT-led Triage in Secondary Care Settings for Patients With Hip or/and Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04665908
- Acronym / sponsor ID
- Triage and hip/knee OA
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Keywords
- PT-led triage, Osteoarthritis, Knee, Hip
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 675 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Dec 2020 (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.
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 explore patients expectations and experiences of PT-led triage in a secondary care setting.
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 qualitative approach will be used to further investigate patients expectations and experience of a PT-led trige.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PT-led triage | Other | Other: Assessment by PT/Orth surgeonPatients are assessed by PT |
| Standard care | Other | Other: Assessment by PT/Orth surgeonThe patiens are assessed by a orthopedic surgeon |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Referred to Sahlgrenska University hospital
- Primary osteoarthritis in the hip or knee
- Understanding and speaking Swedish
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Assessment by PT/Orth surgeonAssessment by orthopaedic surgeon or a PT | Other | PT-led triage, Standard care |
Primary outcome
Short form of the Quality from Patients Perspective (QPP)
Time frame: Baseline
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
4 secondary outcomes
Heath-related quality of life - EuroQol (EQ5-D)
Time frame: Baseline, 3 and 12 months
Pain Disability index (PDI
Time frame: Baseline, 3 and 12 months
Forgotten Joint Score (FJS)
Time frame: Basline, 3 and 12 months
Oxford Hip/Knee Score (OHS/OHK
Time frame: Basline, 3 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 42414961Gustavsson L, Broman D, Beischer S, Samsson K. In safe hands - patients with knee and hip osteoarthritis expectations and experience of physical therapist-led triage in a secondary care setting. BMC Musculoskelet Disord. 2026 Jul 7;27(1):584. doi: 10.1186/s12891-026-10179-3.
- Derived from this study: PubMed 37386368Gustavsson L, Mohaddes M, Samsson K, Beischer S. No major difference in perceived quality of care in patients with hip or knee osteoarthritis assessed in a physical therapy-led triage compared with standard care: a randomized controlled trial. BMC Musculoskelet Disord. 2023 Jun 29;24(1):530. doi: 10.1186/s12891-023-06659-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment by PT/Orth surgeon in people with Knee Osteoarthritis and Hip Osteoarthritis, run by Sahlgrenska University Hospital at 2 sites in Sweden.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short form of the Quality from Patients Perspective (QPP) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04665908, which also lists 2 linked publications.
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 11 May 2025.