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

Hallux Rigidus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02904447
• Other study ID #: HEMICAP
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: November 27, 2017
• Start date: September 2016
• Est. completion date: February 2017

Study information

• Verified date: November 2017
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hallux Limitus
• Hallux Rigidus

Intervention

Other:
• x-ray and pedobar foot pressure mapping

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plantar forces under the hallux and the forefoot in patients operated with a hemiCAP in the 1st MTPJ.	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.	One examination for each patient, approximately 30 min.
Secondary	Range of motion (degrees)	Unit: degrees. ROM of the hemicap operated 1st MTPJ	One examination for each patient, approximately 30 min.
Secondary	Level of pain	Visual analog scale, 1-10 of the hemicap operated foot	One examination for each patient, approximately 30 min.