Effects on Patient Satisfaction and Gait After Loss of Peroneus Longus Function
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04635046|
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
|Condition or disease||Intervention/treatment|
|Patient Satisfaction Gait, Rigid||Procedure: Transfer or extirpation of the peroneus longs tendon|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
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
- 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.
- 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.
- 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.
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
|Contact: Anna E Sprinchorn, MDemail@example.com|
|Contact: Karl Michaelsson, PhD||+4618611 firstname.lastname@example.org|
|Study Chair:||Karl Michaelsson, PhD||Professor|