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

Sponsor
Haraldsplass Deaconess Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05119088
Collaborator
Haukeland University Hospital (Other)
80
1
35.9
2.2

Study Details

Study Description

Brief Summary

About six months after patellastabilizing 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Return to Sport testbattery
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability
Actual Study Start Date :
Jan 4, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Banff Patellofemoral Instability Instrument 2.0 change from pre- to postopertaive score [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. [Baseline and 6 months after surgery.]

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

Secondary Outcome Measures

  1. Forward step down test [Baseline and 6 months after surgery.]

    Is performed on a 20-cm step and evaluates function and movement quality.

  2. Y-balance test [Baseline and 6 months after surgery.]

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

  3. Single legged hop tests [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.

  4. Isokinetic strength test [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.

  5. IKDC-2000 [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.

  6. KOOS [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.

  7. Tampa scale of kinesiophobia [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haraldsplass Deaconess Hospital Bergen Norway 5008

Sponsors and Collaborators

  • Haraldsplass Deaconess Hospital
  • Haukeland University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Trine Hysing-Dahl, Principal Investigator, Haraldsplass Deaconess Hospital
ClinicalTrials.gov Identifier:
NCT05119088
Other Study ID Numbers:
  • 185067
First Posted:
Nov 12, 2021
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2021