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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05119088
Enrollment
120
Registered
2021-11-12
Start date
2021-01-04
Completion date
2023-02-20
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Joint Instability, Patella, Patellofemoral Joint Dislocation

Brief 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.

Interventions

OTHERReturn 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.

Sponsors

Haukeland University Hospital
CollaboratorOTHER
Haraldsplass Deaconess Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Banff Patellofemoral Instability Instrument 2.0 change from pre- to postopertaive scoreBaseline 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.Baseline and 6 months after surgery.Patient-perceived symptoms of patellar instability during activity. It will be administered as a patient completed questionnaire.

Secondary

MeasureTime frameDescription
Isokinetic strength testBaseline and 6 months after surgery.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.
IKDC-2000Baseline and 6 months after surgery.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.
Y-balance testBaseline and 6 months after surgery.Evaluates knee stability and asymmetrical balance in three directions (anterior, posteromedial and posterolateral).
Tampa scale of kinesiophobiaBaseline and 6 months after surgery.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.
KOOSBaseline and 6 months after surgery.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.
Single legged hop testsBaseline and 6 months after surgery.Comprises four tasks: single-leg hop for distance, triple hop for distance, triple cross-over hop for distance and six-meter timed hop.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026