Clinical trial NCT04635046: Effects on Patient Satisfaction and Gait After Loss of Peroneus Longus Function
Official title: Effects on Patient Satisfaction and Gait After Loss of Peroneus Longus Function
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Patient Satisfaction
Gait, Rigid
Keywords: Cavovarus foot
Gait analysis
Tendon transfer
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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 the questionnaires or can not understand Swedish

Primary outcomes:
measure: Changes in quality of life one year after foot surgery including a peroneus longus transfer
timeFrame: Before surgery to 12 months after surgery
measure: Changes in foot function one year after surgery including a peroneus longus transfer
timeFrame: Before surgery to 12 months after surgery
Secondary outcomes:
measure: Weakness in push-off during gait
timeFrame: One year after surgery
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Professor
name: Karl Michaelsson, PhD
role: STUDY_CHAIR
References: