OsteotomyCALCOTNCT03487497
Gait Analysis During Level and Uphill Walking After Lengthening Osteotomy of the Lateral Column
An observational study of Osteotomy and Lengthening; Leg, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
A common surgical treatment for posterior tibial tendon dysfunction (and the resulting flat foot) is the correction through a calcaneal lengthening osteotomy of the lateral column (LLC). Clinical studies showed pain relief and functional improvements through different scores. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteotomy, Lengthening; Leg
- What is being tested?
- Lateral column lengthening osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Nov 2017to 31 Dec 2018
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 patients who had undergone lengthening osteotomy of the lateral column of the foot 2 to 10 years prior and 20 age and sex matched healthy subjects
Who may be able to join
- age > 18 years
- age < 70 years
- Patients:
- Unilateral surgery for posterior tibial tendon dysfunction by flexor digitorum longus transfer and lateral lengthening osteotomy of the calcaneus
- Minimum of 2 years postoperatively
Who cannot join
- Neuromuscular disorders affecting gait
- Cardiovascular disease
- Diabetes
- Pregnancy (if unknown, a pregnancy test (urine test) will be performed)
- Body mass index > 35 kg/m2
- Patients:
Show all 12Show fewer
- Additional pathologies that influence the mobility of the ankle joint
- Bilateral surgery
- Use of walking aids
- Healthy control group:
- Lower extremity surgery
- Pain in the lower extremities within the last 6 months
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
A common surgical treatment for posterior tibial tendon dysfunction (and the resulting flat foot) is the correction through a calcaneal lengthening osteotomy of the lateral column (LLC). Clinical studies showed pain relief and functional improvements through different scores. However, according to clinical experience, some patients complain about a limited ankle dorsiflexion after LLC surgery. Several joints of the foot (talocrural, subtalar, talonavicular, calcaneocuboid) contribute to the overall range of motion in foot plantarflexion/dorsiflexion and pronation/supination. Changes in the range of motion in one joint can affect all the other joints. For instance, it was shown that a fusion of the talonavicular joint removes most of the residual hindfoot motion in plantarflexion/dorsiflexion and pronation/supination. Because the lengthening of the lateral column presumably decreases the mobility of the medial column and thus of the talonavicular joint, this surgery can influence the range of motion of the other joints, and hence contribute to the reported decreased ankle dorsiflexion motion.
Patients after LLC have less plantarflexion of the first metatarsal throughout stance of level walking and less inversion of the hindfoot during push-off compared to healthy subjects. Uphill walking requires more ankle plantarflexion and dorsiflexion than level walking. A limitation of the ankle joint mobility especially in dorsiflexion could therefore lead to additional or greater changes in gait patterns (hindfoot and forefoot kinematics) during uphill walking.
Read more
The primary objective is:
- To compare differences in hindfoot and forefoot kinematics between level and uphill treadmill walking in relation to passive range of motion
The secondary objectives are:
- To compare lower leg muscle activation during level and uphill treadmill walking between patients after LLC and healthy subjects
- To test the association between muscle strength, muscle activation patterns and hindfoot and forefoot kinematics during level and uphill walking and heel rise
- To relate clinical outcome of LLC surgery by functional scores to passive range of motion
Read the detailed description
At the initial assessment, written informed consent will be obtained before participants will undergo a clinical exam (inspection and palpation of the foot, measurement of bilateral passive ankle range of motion). All participants will complete the Short Form (SF)36 and the Foot Function Index20 to obtain pain and functional scores (approximate duration: 30 minutes). Participants will be able to familiarize with treadmill walking at their preferred walking speed. Surface electrodes will be placed bilaterally over the tibialis anterior, gastrocnemius medialis and lateralis, soleus, and peroneus brevis. Isokinetic muscle strength in ankle plantarflexion/ dorsiflexion and inversion/eversion will be tested using the Biodex system 4 Pro (approximate duration: 45 minutes). Reflective surface markers will be placed bilaterally on anatomic landmarks according to the Plug In Gait model and a specific foot model. These markers are seen by 6 Vicon MX cameras. Participants will be asked to stand on the treadmill (h/p cosmos, Zebris), and data for a standing reference trial will be collected. Single-limb heel rise performance with each leg will be tested on the treadmill while kinematic, electromyography (EMG), and pressure data will be measured. Participants will then walk barefoot for 2 minutes at 0% slope while kinematic, EMG, and pressure data will be recorded. Subsequently, the treadmill incline will be increased to 15%, and data for 2 minutes walking at this slope will be recorded followed by three heel rises (approximate duration: 45 minutes). The estimated total time for each participant is 120 minutes.
- Conditions
- Osteotomy, Lengthening; Leg
- Being tested
- Lateral column lengthening osteotomy
- Keywords
- gait analysis, electromyography, strength test, walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral column lengthening osteotomyProcedure or surgery
Lengthening osteotomy of the lateral column of the foot
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who underwent lateral column lengthening osteotomy Receives: Procedure: Lateral column lengthening osteotomy | |
| Healthy subjects | Healthy subjects without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive plantarflexion and dorsiflexion range of motion
measured using a Biodex
Measured: 0 months
Secondary outcomes (5)
3D hindfoot and forefoot range of motion during level and uphill walking
assessed as max plantarflexion to max dorsiflexion of the ankle using marker and camera based motion capture
Measured: 0 months
Isokinetic strength in plantarflexion, dorsiflexion, inversion, and eversion
Max moment assessed using a Biodex
Measured: 0 months
Lower leg muscle activation
Max electromyographic signal intensity
Measured: 0 months
Clinical outcome
assessed by American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score (questionnaires) (best score: 100 - no limitations)
Measured: 0 months
Functional outcome
assessed by Foot Function Index (questionnaire) (best score: 0; worst score 100)
Measured: 0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start20 Nov 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteotomyStudies 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
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corina Nüesch, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487497
- Sponsor's protocol ID
- 2015-00254
- Other IDs
- 2015
- Acronym
- CALCOT
- Status last verified
- Feb 2020
- First submitted
- 28 Feb 2018
- Last updated
- 2 Mar 2020
- 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 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis During Level and Uphill Walking After Lengthening Osteotomy of the Lateral Column
- ClinicalTrials.gov ID
- NCT03487497
- Acronym / sponsor ID
- CALCOT / 2015-00254
- Conditions
- Osteotomy, Lengthening; Leg
- Keywords
- gait analysis, electromyography, strength test, walking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Apr 2018 (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.
A common surgical treatment for posterior tibial tendon dysfunction (and the resulting flat foot) is the correction through a calcaneal lengthening osteotomy of the lateral column (LLC). Clinical studies showed pain relief and functional improvements through different scores. However, according to clinical experience, some patients complain about a limited ankle dorsiflexion after LLC surgery. Several joints of the foot (talocrural, subtalar, talonavicular, calcaneocuboid) contribute to the overall range of motion in foot plantarflexion/dorsiflexion and pronation/supination. Changes in the range of motion in one joint can affect all the other joints. For instance, it was shown that a fusion of the talonavicular joint removes most of the residual hindfoot motion in plantarflexion/dorsiflexion and pronation/supination. Because the lengthening of the lateral column presumably decreases the mobility of the medial column and thus of the talonavicular joint, this surgery can influence the range of motion of the other joints, and hence contribute to the reported decreased ankle dorsiflexion motion.
Patients after LLC have less plantarflexion of the first metatarsal throughout stance of level walking and less inversion of the hindfoot during push-off compared to healthy subjects. Uphill walking requires more ankle plantarflexion and dorsiflexion than level walking. A limitation of the ankle joint mobility especially in dorsiflexion could therefore lead to additional or greater changes in gait patterns (hindfoot and forefoot kinematics) during uphill walking.
The primary objective is:
- To compare differences in hindfoot and forefoot kinematics between level and uphill treadmill walking in relation to passive range of motion
The secondary objectives are:
- To compare lower leg muscle activation during level and uphill treadmill walking between patients after LLC and healthy subjects
- To test the association between muscle strength, muscle activation patterns and hindfoot and forefoot kinematics during level and uphill walking and heel rise
- To relate clinical outcome of LLC surgery by functional scores to passive range of motion
Detailed description
At the initial assessment, written informed consent will be obtained before participants will undergo a clinical exam (inspection and palpation of the foot, measurement of bilateral passive ankle range of motion). All participants will complete the Short Form (SF)36 and the Foot Function Index20 to obtain pain and functional scores (approximate duration: 30 minutes). Participants will be able to familiarize with treadmill walking at their preferred walking speed. Surface electrodes will be placed bilaterally over the tibialis anterior, gastrocnemius medialis and lateralis, soleus, and peroneus brevis. Isokinetic muscle strength in ankle plantarflexion/ dorsiflexion and inversion/eversion will be tested using the Biodex system 4 Pro (approximate duration: 45 minutes). Reflective surface markers will be placed bilaterally on anatomic landmarks according to the Plug In Gait model and a specific foot model. These markers are seen by 6 Vicon MX cameras. Participants will be asked to stand on the treadmill (h/p cosmos, Zebris), and data for a standing reference trial will be collected. Single-limb heel rise performance with each leg will be tested on the treadmill while kinematic, electromyography (EMG), and pressure data will be measured. Participants will then walk barefoot for 2 minutes at 0% slope while kinematic, EMG, and pressure data will be recorded. Subsequently, the treadmill incline will be increased to 15%, and data for 2 minutes walking at this slope will be recorded followed by three heel rises (approximate duration: 45 minutes). The estimated total time for each participant is 120 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Lateral column lengthening osteotomyPatients who underwent lateral column lengthening osteotomy |
| Healthy subjects | – | –Healthy subjects without intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients who had undergone lengthening osteotomy of the lateral column of the foot 2 to 10 years prior and 20 age and sex matched healthy subjects
Key inclusion criteria (5 listed)
- age > 18 years
- age < 70 years
- Patients:
- Unilateral surgery for posterior tibial tendon dysfunction by flexor digitorum longus transfer and lateral lengthening osteotomy of the calcaneus
- Minimum of 2 years postoperatively
Key exclusion criteria (12 listed)
- Neuromuscular disorders affecting gait
- Cardiovascular disease
- Diabetes
- Pregnancy (if unknown, a pregnancy test (urine test) will be performed)
- Body mass index > 35 kg/m2
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 |
|---|---|---|
| Lateral column lengthening osteotomyLengthening osteotomy of the lateral column of the foot | Procedure or surgery | Patients |
Primary outcome
Passive plantarflexion and dorsiflexion range of motion
Time frame: 0 months
measured using a Biodex
5 secondary outcomes
3D hindfoot and forefoot range of motion during level and uphill walking
Time frame: 0 months
Isokinetic strength in plantarflexion, dorsiflexion, inversion, and eversion
Time frame: 0 months
Lower leg muscle activation
Time frame: 0 months
Clinical outcome
Time frame: 0 months
Functional outcome
Time frame: 0 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Osteotomy
Not yet recruiting
Hybrid Closed Wedge High Tibial Osteotomy
Patello-femoral Osteoarthritis
Not yet recruitingPhase 3
Phase 3 Bunionectomy Study
Postoperative Pain, Bunion
Recruiting
Subchondral Drilling Diameter During CARTISTEM Implantation for Knee Cartilage Defects
Osteoarthritis, Knee, Articular Cartilage Defects of the Knee
Not yet recruitingPhase 3
Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy
Cerebral Palsy, Hip Surgery Corrective
Recruiting
Bony Overlap Following Use of the Inferior Border Saw for the 'Low and Short' Sagittal Split: A Split-Mouth Study
Mandibular Surgery
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.
Corina Nüesch, PhD principal investigator
University Hospital, Basel, Switzerland
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 Osteotomy and Lengthening; Leg, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 2 Mar 2020. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Passive plantarflexion and dorsiflexion range of motion (time frame: 0 months). 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 2 Mar 2020.