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Effects on Patient Satisfaction and Gait After Loss of Peroneus Longus Function

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ClinicalTrials.gov Identifier: NCT04635046
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Anna Sprinchorn, Uppsala University

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.

Condition or disease Intervention/treatment
Patient Satisfaction Gait, Rigid Procedure: Transfer or extirpation of the peroneus longs tendon

Detailed Description:

The patients are asked to fill in Short Form 36 (SF 36) and Foot and Ankle Outcome Score (FAOS) before surgery, six months and one year after surgery. At each visit a clinical examination is done by a foot and ankle surgeon, according to a protocol. At the same visit a gait analysis is performed with force plates, registration of speed and gait length and 3D recording. The surgery itself is performed according to the clinic's usual protocol and standardised, so all patients are treated in the same way. The physiotherapy is also done according to a protocol. The surgeon is not involved in the follow- up, this is done by another surgeon, and the gait analysis is done by a physiotherapist.

The patients are chosen from two groups: primary tear of the peroneus brevis tendon, requiring a longus to brevis transfer, and primary tear of the peroneus longus tendon, requiring removal of the tendon.

The first group has a sub-group: patients who are in need of a calcaneal osteotomy because of a severe varus hindfoot. The reason the study group is so heterogenous is that peroneus longus and brevis tears are very rare, and 10 patients are referred to the Orthoaedic deparment each year, that need this type of surgery. The sample size has been calculated to 30 patients (based on changes in force measurements during gate), but more patients need to be involved in the study in order to have 30 patients at one year follow up.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects on Patient Satisfaction and Gait After Loss of Peroneus Longus Function
Actual Study Start Date : May 30, 2016
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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




Primary Outcome Measures :
  1. Changes in quality of life one year after foot surgery including a peroneus longus transfer [ Time Frame: Before surgery to 12 months after surgery ]
    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.

  2. Changes in foot function one year after surgery including a peroneus longus transfer [ Time Frame: Before surgery to 12 months after surgery ]
    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.


Secondary Outcome Measures :
  1. Weakness in push-off during gait [ Time Frame: One year after surgery ]
    After removal of the peroneus longus tendon one might observe a weakness in the plantar flexion of the first metatarsal bone, leading to a weakness in push off during gait. This will be measured on the RSscan pressure mat (from RSscan International), recording the pressure at push-off in Newtons/ m2. The patient will be walking both bare foot and with shoes. Measurements are done before surgery, at 6 months and 12 months after surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Other injuries in the affected foot that might affect the gait.
  2. Previous surgery in the affected foot that might affect the gait.
  3. Neurological conditions in the lower extremities that might affect the gait.
  4. Patient can not understand Swedish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635046


Contacts
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Contact: Anna E Sprinchorn, MD +46708343808 anna.sprinchorn@surgsci.uu.se
Contact: Karl Michaelsson, PhD +4618611 9545 karl.michaelsson@surgsci.uu.se

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden, 751 85
Contact: Anna E Sprinchorn, MD    +46708343808    anna.sprinchorn@surgsci.uu.se   
Contact: Catarina Stromstedt, Nurse    +46186119035    catharina.stromstedt@akademiska.se   
Sponsors and Collaborators
Anna Sprinchorn
Investigators
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Study Chair: Karl Michaelsson, PhD Professor
  Study Documents (Full-Text)

Documents provided by Anna Sprinchorn, Uppsala University:
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Responsible Party: Anna Sprinchorn, Principal Investigator, Uppsala University
ClinicalTrials.gov Identifier: NCT04635046    
Other Study ID Numbers: 2015/428
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Sprinchorn, Uppsala University:
Cavovarus foot
Gait analysis
Tendon transfer
Additional relevant MeSH terms:
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Gait Disorders, Neurologic
Neurologic Manifestations
Nervous System Diseases