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Clinical Trials/NCT05119088
NCT05119088CompletedNot Applicable

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

Haraldsplass Deaconess Hospital1 site in 1 country120 target enrollmentStarted: January 4, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Norwich patellar Instability score change from pre- to postopertaive score.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
13 Years to 45 Years (Child, Adult)
Sex
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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Single legged hop tests(Baseline and 6 months after surgery.)
  • Isokinetic strength test(Baseline and 6 months after surgery.)
  • Y-balance test(Baseline and 6 months after surgery.)
  • IKDC-2000(Baseline and 6 months after surgery.)
  • KOOS(Baseline and 6 months after surgery.)
  • Tampa scale of kinesiophobia(Baseline and 6 months after surgery.)

Investigators

Sponsor
Haraldsplass Deaconess Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Trine Hysing-Dahl

Principal Investigator

Haraldsplass Deaconess Hospital

Study Sites (1)

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