PatellaNCT05119088
Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability
A study testing Return to Sport testbattery in people with Patella and Joint Instability, run by Haraldsplass Deaconess Hospital at 1 site in Norway.
Trial summary
About six months after patella stabilizing surgery postoperative restrictions are commonly lifted and patients may consider whether a return to activity/sports is feasible. Currently, there are no evidence-based criteria to determine a patients readiness for sports and/or activity (RTS) following stabilizing surgery. Read more about this study
- Who is it for?
- Ages 13 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Patella, Joint Instability, Patellofemoral Joint Dislocation
- What is being tested?
- Return to Sport testbattery
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 4 Jan 2021to 20 Feb 2023
- 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 13 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients who have undergone surgical treatment for recurrent patellar dislocation in Helse Vest. The investigators will include patients with reconstruction of the medial patella femoral ligament, trochleaplasty, tibial tubercle osteotomy, Insall or concomitant procedures.
Who cannot join
- Unable to give written informed consent.
- Medial patellar dislocation.
- unable to understand written or spoken Norwegian.
- patients with other knee injuries.
Trial locations and contacts
1 site in 1 country.
About this study
About six months after patella stabilizing surgery postoperative restrictions are commonly lifted and patients may consider whether a return to activity/sports is feasible. Currently, there are no evidence-based criteria to determine a patients readiness for sports and/or activity (RTS) following stabilizing surgery. The purpose of this project was therefore to investigate the feasibility of a test battery to evaluate knee function in postoperative follow-up evaluation - and in RTS decisions - for patients with patellar instability. Banff Patellofemoral Instability Instrument 2.0 and Norwich Patellar Instability Score is being translated and validatend in a Norwegian population. Furter is patients experience of living with patellar instability explored.
- Conditions
- Patella, Joint Instability, Patellofemoral Joint Dislocation
- Being tested
- Return to Sport testbattery
- Medical subject headings
- Patella Fracture, Joint Instability, Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Return to Sport testbatteryOther
Also called Validation of Banff Patellofemoral Instability Instrument 2.0 - No, Validation of Norwich Instability Score - No
At baseline, approximately 3 weeks before surgery and 6 months after surgery: patients conduct a testbattery consisting of 2 PROMs: the NPI-No and BPII2.0-No together with three physical tests: isokinetic strength tests, hop tests and Y-balance test. For the cross-cultural validation of NPI and BPII2.0 patients also conduct KOOS, IKDC 2000 and Tampa Scale.
What is being measured
The primary outcome is the main question the study is designed to answer.
Banff Patellofemoral Instability Instrument 2.0 change from pre- to postopertaive score
Self-administered, disease-specific quality of life score. It will be administered as a patient completed questionnaire.
Measured: Baseline and 6 months after surgery.
Norwich patellar Instability score change from pre- to postopertaive score.
Patient-perceived symptoms of patellar instability during activity. It will be administered as a patient completed questionnaire.
Measured: Baseline and 6 months after surgery.
Secondary outcomes (6)
Y-balance test
Evaluates knee stability and asymmetrical balance in three directions (anterior, posteromedial and posterolateral).
Measured: Baseline and 6 months after surgery.
Single legged hop tests
Comprises four tasks: single-leg hop for distance, triple hop for distance, triple cross-over hop for distance and six-meter timed hop.
Measured: Baseline and 6 months after surgery.
Isokinetic strength test
Strength testing of knee extension / flexion (Biodex system 4 dynamometer, Biodex Medical Systems Inc., Shirley, New York). With a standardized protocol of five repetitions at 60 o/sec and 30 repetitions at 240 o/sec.
Measured: Baseline and 6 months after surgery.
IKDC-2000
Is a knee-specific, patient reported tool, including 18 questions across three domains: symptoms, physical activity and function. It will be administered as a patient completed questionnaire.
Measured: Baseline and 6 months after surgery.
KOOS
Is an instrument to assess the patient's opinion about their knee and associated problems. It comprises five domains: pain, other symptoms, function in daily living, function in sports and recreational activities and knee-related QOL. It will be administered as a patient completed questionnaire.
Measured: Baseline and 6 months after surgery.
Tampa scale of kinesiophobia
TSK is a 17-item patient-reported questionnaire aimed at quantifying the fear of re-injuries due to movement and physical activity. It will be administered as a patient completed questionnaire.
Measured: Baseline and 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start4 Jan 2021
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
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 PatellaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haraldsplass Deaconess Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Principal investigator, Trine Hysing-Dahl, Haraldsplass Deaconess Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119088
- Sponsor's protocol ID
- 185067
- Status last verified
- Feb 2023
- First submitted
- 5 Oct 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hysing-Dahl T, Magnussen LH, Faleide AGH, Inderhaug E. Feasibility of return to sports assessment 6 months after patellar instability surgery. BMC Musculoskelet Disord. 2023 Aug 18;24(1):662. doi: 10.1186/s12891-023-06767-2.
PubMed 37596551Hysing-Dahl T, Inderhaug E, Faleide AGH, Magnussen LH. Patients' experiences of living with patellar instability before and after surgery: a qualitative interview study. BMJ Open. 2023 Jun 9;13(6):e072141. doi: 10.1136/bmjopen-2023-072141.
PubMed 37295823
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability
- ClinicalTrials.gov ID
- NCT05119088
- Acronym / sponsor ID
- 185067
- Conditions
- Patella, Joint Instability, Patellofemoral Joint Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Haraldsplass Deaconess HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 12 Nov 2021 (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.
About six months after patella stabilizing surgery postoperative restrictions are commonly lifted and patients may consider whether a return to activity/sports is feasible. Currently, there are no evidence-based criteria to determine a patients readiness for sports and/or activity (RTS) following stabilizing surgery. The purpose of this project was therefore to investigate the feasibility of a test battery to evaluate knee function in postoperative follow-up evaluation - and in RTS decisions - for patients with patellar instability. Banff Patellofemoral Instability Instrument 2.0 and Norwich Patellar Instability Score is being translated and validatend in a Norwegian population. Furter is patients experience of living with patellar instability explored.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients who have undergone surgical treatment for recurrent patellar dislocation in Helse Vest. The investigators will include patients with reconstruction of the medial patella femoral ligament, trochleaplasty, tibial tubercle osteotomy, Insall or concomitant procedures.
Key exclusion criteria (4 listed)
- Unable to give written informed consent.
- Medial patellar dislocation.
- unable to understand written or spoken Norwegian.
- patients with other knee injuries.
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 |
|---|---|---|
| Return to Sport testbatteryAlso: Validation of Banff Patellofemoral Instability Instrument 2.0 - No, Validation of Norwich Instability Score - NoAt baseline, approximately 3 weeks before surgery and 6 months after surgery: patients conduct a testbattery consisting of 2 PROMs: the NPI-No and BPII2.0-No together with three physical tests: isokinetic strength tests, hop tests and Y-balance test. For the cross-cultural validation of NPI and BPII2.0 patients also conduct KOOS, IKDC 2000 and Tampa Scale. | Other | – |
Primary outcome
Banff Patellofemoral Instability Instrument 2.0 change from pre- to postopertaive score
Time frame: Baseline and 6 months after surgery.
Self-administered, disease-specific quality of life score. It will be administered as a patient completed questionnaire.
Norwich patellar Instability score change from pre- to postopertaive score.
Time frame: Baseline and 6 months after surgery.
Patient-perceived symptoms of patellar instability during activity. It will be administered as a patient completed questionnaire.
6 secondary outcomes
Y-balance test
Time frame: Baseline and 6 months after surgery.
Single legged hop tests
Time frame: Baseline and 6 months after surgery.
Isokinetic strength test
Time frame: Baseline and 6 months after surgery.
IKDC-2000
Time frame: Baseline and 6 months after surgery.
KOOS
Time frame: Baseline and 6 months after surgery.
Tampa scale of kinesiophobia
Time frame: Baseline and 6 months after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 37596551Hysing-Dahl T, Magnussen LH, Faleide AGH, Inderhaug E. Feasibility of return to sports assessment 6 months after patellar instability surgery. BMC Musculoskelet Disord. 2023 Aug 18;24(1):662. doi: 10.1186/s12891-023-06767-2.
- Derived from this study: PubMed 37295823Hysing-Dahl T, Inderhaug E, Faleide AGH, Magnussen LH. Patients' experiences of living with patellar instability before and after surgery: a qualitative interview study. BMJ Open. 2023 Jun 9;13(6):e072141. doi: 10.1136/bmjopen-2023-072141.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Return to Sport testbattery in people with Patella and Joint Instability, run by Haraldsplass Deaconess Hospital at 1 site in Norway.
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 1 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: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Banff Patellofemoral Instability Instrument 2.0 change from pre- to postopertaive score (time frame: Baseline and 6 months after surgery.). The study lists 2 primary outcomes in all. 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 NCT05119088, 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 1 Mar 2023.