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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05119088
Other study ID # 185067
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2021
Est. completion date February 20, 2023

Study information

Verified date February 2023
Source Haraldsplass Deaconess Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date February 20, 2023
Est. primary completion date February 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 45 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Unable to give written informed consent. - Medial patellar dislocation. - unable to understand written or spoken Norwegian. - patients with other knee injuries.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Return to Sport testbattery
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.

Locations

Country Name City State
Norway Haraldsplass Deaconess Hospital Bergen

Sponsors (2)

Lead Sponsor Collaborator
Haraldsplass Deaconess Hospital Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and 6 months after surgery.
Primary 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. Baseline and 6 months after surgery.
Secondary Y-balance test Evaluates knee stability and asymmetrical balance in three directions (anterior, posteromedial and posterolateral). Baseline and 6 months after surgery.
Secondary 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. Baseline and 6 months after surgery.
Secondary 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. Baseline and 6 months after surgery.
Secondary 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. Baseline and 6 months after surgery.
Secondary 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. Baseline and 6 months after surgery.
Secondary 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. Baseline and 6 months after surgery.
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