NCT04635046

Brief Summary

At the foot and ankle group at the Department of Orthopaedics, Uppsala University Hospital, the routine is to perform a tendon transfer of peroneus longus to brevis in case of a ruptured peroneus brevis tendon in the ankle. The reports of patient outcome from this surgery varies in different studies. The aim of the current study is to analyse how well the patients think their general health has improved after the surgery, and how they perceive that the foot function has changed after the surgery. In an objective way the changes in gait after surgery will be measured with gait analysis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 30, 2016

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

7.9 years

First QC Date

September 18, 2020

Last Update Submit

November 29, 2023

Conditions

Patient SatisfactionGait, Rigid

Keywords

Cavovarus footGait analysisTendon transfer

Outcome Measures

Primary Outcomes (2)

  • Changes in quality of life one year after foot surgery including a peroneus longus transfer

    Patients quality of life is measured with the self-administered Short Form 36 ( SF 36 ) (range 0-100 points, 100 points best health) before surgery, at 6 months and 12 months after surgery.

    Before surgery to 12 months after surgery

  • Changes in foot function one year after surgery including a peroneus longus transfer

    Changes in foot function after surgery is measured using a patient reported outcome measure: Foot and Ankle Outcome Score (FAOS) (range 0-100 points, 100 points being a totally healthy foot). The patient fill in the score before surgery, at 6 months and 12 months after surgery.

    Before surgery to 12 months after surgery

Secondary Outcomes (1)

  • Weakness in push-off during gait

    One year after surgery

Study Arms (1)

Patients with tears to their peroneal tendons

Patients with pain over their peroneal tendons clinically, with a verified injury to either of the two tendons on MRI, where we might expect a tendon transfer of the peroneus longus, or extirpation of the peroneus longus, during surgery.

Procedure: Transfer or extirpation of the peroneus longs tendon

Interventions

Transfer or extirpation of the peroneus longs tendonPROCEDURE

Tendon transfer or extirpation of peroneus longus or brevis tendon, ligamental reconstruction +/- calcaneal osteotomy

Patients with tears to their peroneal tendons

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that are referred to the Foot and Ankle Clinic at Uppsala University Hospital with a tear to the peroneus brevis or longus tendon where we plan for surgery, and who are willing to participate in the study after information about the study.

You may qualify if:

  • Tears of the peroneus longus and/or peroneus brevis tendon, verified on MRI.
  • Eligible for surgery of peroneal tendon tears

You may not qualify if:

  • Other injuries in the affected foot that might affect the gait.
  • Previous surgery in the affected foot that might affect the gait.
  • Neurological conditions in the lower extremities that might affect the gait.
  • Patient can not understand the questionnaires or can not understand Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

MeSH Terms

Conditions

Patient SatisfactionGait Disorders, Neurologic

Interventions

Parturition

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Karl Michaelsson, PhD

    Professor

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2020

First Posted

November 18, 2020

Study Start

May 30, 2016

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)