An interventional study of Return to Sport testbattery in Patella, Joint Instability and Patellofemoral Joint Dislocation, sponsored by Haraldsplass Deaconess Hospital. Completed at 1 site in Norway. Open to participants aged 13 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Haraldsplass Deaconess Hospital · Not applicable, Interventional, and Other
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.
40 studies on the registry are indexed under Patella Fracture; 9 are open to participants now.
This study's enrollment of 120 is above the median of 53 across 30 interventional studies indexed under Patella Fracture.
Browse Patella Fracture studies →Haraldsplass Deaconess Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Validation of Banff Patellofemoral Instability Instrument 2.0 - No, Validation of Norwich Instability Score - No
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.
Time frame: 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.
Time frame: Baseline and 6 months after surgery.
Y-balance test
Evaluates knee stability and asymmetrical balance in three directions (anterior, posteromedial and posterolateral).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 6 months after surgery.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Feb 2023, 25 months.
Of 18 interventional studies with no phase under Patella Fracture, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 136. This study's 25 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Haraldsplass Deaconess Hospital