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

NCT ID: NCT05119088

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2023-02-20

Brief Summary

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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.

Detailed Description

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Conditions

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Patella Joint Instability Patellofemoral Joint Dislocation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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Return to Sport testbattery

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.

Intervention Type OTHER

Other Intervention Names

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Validation of Banff Patellofemoral Instability Instrument 2.0 - No Validation of Norwich Instability Score - No

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

Haraldsplass Deaconess Hospital

OTHER

Sponsor Role lead

Responsible Party

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Trine Hysing-Dahl

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haraldsplass Deaconess Hospital

Bergen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 37596551 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37295823 (View on PubMed)

Other Identifiers

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185067

Identifier Type: -

Identifier Source: org_study_id

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