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

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04635046
• Other study ID #: 2015/428
• Status: Active, not recruiting
• Start date: May 30, 2016
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 the questionnaires or can not understand Swedish

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Rigid
• Patient Satisfaction

Intervention

Procedure:
• Transfer or extirpation of the peroneus longs tendon
Tendon transfer or extirpation of peroneus longus or brevis tendon, ligamental reconstruction +/- calcaneal osteotomy

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Anna Sprinchorn

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Weakness in push-off during gait	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.	One year after surgery