Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability

Joint Instability Clinical Trial

Official title:

Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119088
• Other study ID #: 185067
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Joint Instability
• Patella
• Patellar Dislocation

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.