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Completed

NCT Number: NCT02904447

Plantar Forces Mid-term After Hemiarthroplasty With HemiCap for Hallux Rigidus

The purpose of this study is to examine variabel pressure gradients of the 1st toe, 2-5th toes and the metatarsal distal caput in patients who have had surgery with a partial proximal hemiarthroplasty in the 1st metatarsalphalangeal joint (MTP) between 2006-2014.

Also, to examine these variables and compare them to the totalt range of motion and pain, to find out if the measured pedobar pressure can be used identify the well treated patient and the poorly treated patient.

The pedobar pressure gradients will be compared with a control group with healthy feet.

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Key information

Conditions

Hallux Rigidus Foot Deformities Foot Deformities, Acquired Joint Diseases Musculoskeletal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre Hospital

Hvidovre, Copenhagen, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who has hemicap 1. MTP joint.

Exclusion criteria

  • patients who haad revision surgery, for example removal of hemicap and desis og 1. MTP joint.

Treatment and study plan

x-ray and pedobar foot pressure mapping

Other

Primary outcomes

  1. Plantar forces under the hallux and the forefoot in patients operated with a hemiCAP in the 1st MTPJ.

    Time frame: One examination for each patient, approximately 30 min.

    Plantar forces are measured under the hallux and the forefoot (plantar pressure (kPa), maximal force (N), and force/time (N/s)) is measured by the Emed foot pressure mapping system.

Secondary outcomes

  1. Range of motion (degrees)

    Time frame: One examination for each patient, approximately 30 min.

    Unit: degrees. ROM of the hemicap operated 1st MTPJ

  2. Level of pain

    Time frame: One examination for each patient, approximately 30 min.

    Visual analog scale, 1-10 of the hemicap operated foot

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2016
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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