NCT03487497

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

February 28, 2018

Last Update Submit

February 28, 2020

Conditions

Keywords

gait analysiselectromyographystrength testwalking

Outcome Measures

Primary Outcomes (1)

  • Passive plantarflexion and dorsiflexion range of motion

    measured using a Biodex

    0 months

Secondary Outcomes (5)

  • 3D hindfoot and forefoot range of motion during level and uphill walking

    0 months

  • Isokinetic strength in plantarflexion, dorsiflexion, inversion, and eversion

    0 months

  • Lower leg muscle activation

    0 months

  • Clinical outcome

    0 months

  • Functional outcome

    0 months

Study Arms (2)

Patients

Patients who underwent lateral column lengthening osteotomy

Procedure: Lateral column lengthening osteotomy

Healthy subjects

Healthy subjects without intervention

Interventions

Lengthening osteotomy of the lateral column of the foot

Patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Study Officials

  • Corina Nüesch, PhD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

April 4, 2018

Study Start

November 20, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations