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

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 Overview

• Status: Completed
• Conditions: Patellofemoral Joint Dislocation; Joint Instability; Patella
• Intervention / Treatment: Other: Return to Sport testbattery

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5008
    • Haraldsplass Deaconess Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Y-balance test	Evaluates knee stability and asymmetrical balance in three directions (anterior, posteromedial and posterolateral).	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.	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.	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.	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.	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.	Baseline and 6 months after surgery.

Collaborators and Investigators

• Sponsor: Haraldsplass Deaconess Hospital
• Collaborators: Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Joint Dislocations; Patellar Dislocation; Joint Instability
• Other Study ID Numbers: 185067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No