Patient SatisfactionNCT04635046
Effects on Patient Satisfaction and Gait After Loss of Peroneus Longus Function
An observational study of Patient Satisfaction and Gait, Rigid, run by Anna Sprinchorn at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction, Gait, Rigid
- What is being tested?
- Transfer or extirpation of the peroneus longs tendon
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 30 May 2016to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Tears of the peroneus longus and/or peroneus brevis tendon, verified on MRI.
- Eligible for surgery of peroneal tendon tears
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Patient Satisfaction, Gait, Rigid
- Being tested
- Transfer or extirpation of the peroneus longs tendon
- Keywords
- Cavovarus foot, Gait analysis, Tendon transfer
- Medical subject headings
- Patient Satisfaction, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfer or extirpation of the peroneus longs tendonProcedure or surgery
Tendon transfer or extirpation of peroneus longus or brevis tendon, ligamental reconstruction +/- calcaneal osteotomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Transfer or extirpation of the peroneus longs tendon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before surgery to 12 months after surgery
Secondary outcomes (1)
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.
Measured: One year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start30 May 2016
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Sprinchorn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Sprinchorn, Uppsala University
- Investigators
- Karl Michaelsson, PhD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635046
- Sponsor's protocol ID
- 2015/428
- Status last verified
- Nov 2023
- First submitted
- 18 Sep 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Patient Satisfaction and Gait After Loss of Peroneus Longus Function
- ClinicalTrials.gov ID
- NCT04635046
- Acronym / sponsor ID
- 2015/428
- Conditions
- Patient Satisfaction, Gait, Rigid
- Keywords
- Cavovarus foot, Gait analysis, Tendon transfer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Anna SprinchornUniversity, hospital or other
- Study start
- 30 May 2016 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with tears to their peroneal tendons | – | Procedure: Transfer or extirpation of the peroneus longs tendonPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Tears of the peroneus longus and/or peroneus brevis tendon, verified on MRI.
- Eligible for surgery of peroneal tendon tears
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfer or extirpation of the peroneus longs tendonTendon transfer or extirpation of peroneus longus or brevis tendon, ligamental reconstruction +/- calcaneal osteotomy | Procedure or surgery | Patients with tears to their peroneal tendons |
Primary outcome
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.
1 secondary outcome
Weakness in push-off during gait
Time frame: One year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Patient Satisfaction
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
Recruiting
Effect of Mandala Coloring on Anxiety, Pain, Vital Signs, and Patient Satisfaction in Patients Undergoing Transurethral Resection of the Prostate
Mandala Coloring
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Michaelsson, PhD study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction and Gait, Rigid, run by Anna Sprinchorn at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quality of life one year after foot surgery including a peroneus longus transfer (time frame: Before surgery to 12 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.