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

NCT02904447 | Completed DMC

• 1 other identifier: HEMICAP
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hallux Rigidus

Keywords

hemicap; hallux rigidus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Range of motion (degrees)

  One examination for each patient, approximately 30 min.

• Level of pain

  One examination for each patient, approximately 30 min.

Interventions

x-ray and pedobar foot pressure mapping OTHER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who has had an operation with proximal hemiarthroplasty (hemicap) 1st MTP proximal prosthetics 2006-2014 in Hvidovre Hospital, Glostrup Hospital or Hamlet-Aleris Hospital.

You may qualify if:

• patients who has hemicap 1. MTP joint.

You may not qualify if:

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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Hvidovre Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

MeSH Terms

Conditions

Hallux Rigidus

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Joint Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reservelæge

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: September 19, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

DK (1)