NCT05119088

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 12, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

October 5, 2021

Last Update Submit

February 28, 2023

Conditions

PatellaJoint InstabilityPatellofemoral Joint Dislocation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Y-balance test

    Baseline and 6 months after surgery.

  • Single legged hop tests

    Baseline and 6 months after surgery.

  • Isokinetic strength test

    Baseline and 6 months after surgery.

  • IKDC-2000

    Baseline and 6 months after surgery.

  • KOOS

    Baseline and 6 months after surgery.

  • +1 more secondary outcomes

Interventions

Return to Sport testbatteryOTHER

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.

Also known as: Validation of Banff Patellofemoral Instability Instrument 2.0 - No, Validation of Norwich Instability Score - No

Eligibility Criteria

Age13 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to give written informed consent.
  • Medial patellar dislocation.
  • unable to understand written or spoken Norwegian.
  • patients with other knee injuries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haraldsplass Deaconess Hospital

Bergen, 5008, Norway

Location

Related Publications (2)

  • Hysing-Dahl T, Magnussen LH, Faleide AGH, Inderhaug E. Feasibility of return to sports assessment 6 months after patellar instability surgery. BMC Musculoskelet Disord. 2023 Aug 18;24(1):662. doi: 10.1186/s12891-023-06767-2.

    PMID: 37596551DERIVED

  • Hysing-Dahl T, Inderhaug E, Faleide AGH, Magnussen LH. Patients' experiences of living with patellar instability before and after surgery: a qualitative interview study. BMJ Open. 2023 Jun 9;13(6):e072141. doi: 10.1136/bmjopen-2023-072141.

    PMID: 37295823DERIVED

MeSH Terms

Conditions

Patella FractureJoint InstabilityPatellar Dislocation

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesJoint DiseasesMusculoskeletal DiseasesJoint DislocationsKnee InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2021

First Posted

November 12, 2021

Study Start

January 4, 2021

Primary Completion

February 20, 2023

Study Completion

February 20, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)