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Completed

NCT Number: NCT05119088

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.

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Key information

Conditions

Patella Fractures, Bone Joint Diseases Joint Dislocations Joint Instability Knee Fractures Knee Injuries Leg Injuries Musculoskeletal Diseases Patella Fracture Patellar Dislocation Patellofemoral Joint Dislocation Wounds and Injuries

Age range

13 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haraldsplass Deaconess Hospital

Bergen, 5008, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Return to Sport testbattery

Other

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.

Other names: Validation of Banff Patellofemoral Instability Instrument 2.0 - No, Validation of Norwich Instability Score - No

Primary outcomes

  1. Banff Patellofemoral Instability Instrument 2.0 change from pre- to postopertaive score

    Time frame: Baseline and 6 months after surgery.

    Self-administered, disease-specific quality of life score. It will be administered as a patient completed questionnaire.

  2. Norwich patellar Instability score change from pre- to postopertaive score.

    Time frame: Baseline and 6 months after surgery.

    Patient-perceived symptoms of patellar instability during activity. It will be administered as a patient completed questionnaire.

Secondary outcomes

  1. Y-balance test

    Time frame: Baseline and 6 months after surgery.

    Evaluates knee stability and asymmetrical balance in three directions (anterior, posteromedial and posterolateral).

  2. Single legged hop tests

    Time frame: Baseline 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.

  3. Isokinetic strength test

    Time frame: Baseline 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.

  4. IKDC-2000

    Time frame: Baseline 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.

  5. KOOS

    Time frame: Baseline 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.

  6. Tampa scale of kinesiophobia

    Time frame: Baseline 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.

Sponsors and collaborators

Lead sponsor

Haraldsplass Deaconess Hospital

Other

Collaborators

  • Haukeland University Hospital

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 12, 2021
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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