NCT04894578

Brief Summary

Group A: Patients suffering from midfoot arthritis after failed prior conservative therapy who undergo a reverse distal metatarsal minimal-invasive osteotomy Group B: Patients suffering from midfoot arthritis after failed prior conservative therapy who undergo a fusion of one or more midfoot (tarsometatarsal) joints

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 11, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

2.6 years

First QC Date

May 11, 2021

Last Update Submit

May 18, 2021

Conditions

OsteoarthritisFootOsteotomy

Outcome Measures

Primary Outcomes (1)

  • Clinical Outcome using a patient related outcome measure, the FAAM score (Validated Foot and Ankle Ability Measure). The score is a self-report outcome instrument developed to assess physical function. The change between the time points is measured.

    FAAM score, the highest score is 100, indicating the best possible outcome

    6 weeks, 3 months, 6 months, 12 and 24 months post surgery

Secondary Outcomes (5)

  • Duration of procedure

    through study completion, an average of 2 years

  • Length of hospital stay

    through study completion, an average of 2 years

  • Visual Analogue Scale (VAS) score. It is a measurement instrument for the amount of pain that a patient feels. The score is assessed preoperatively and the change between the time points is measured.

    6 weeks, 3 months, 6 months, 12 and 24 months post surgery

  • Radiological union by evaluating conventional X-Ray. Preoperative X-Rays and postoperative X-Rays are comparted and the change in union in terms of bone densitiy is assessed postoperatively.

    6 weeks, 3 months, 6 months, 12 and 24 months post surgery

  • Complications

    6 weeks, 3 months, 6 months, 12 and 24 months post surgery

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients suffering from midfoot arthritis after failed prior conservative therapy who undergo a reverse distal metatarsal minimal-invasive osteotomy

Procedure: reverse distal metatarsal minimal-invasive osteotomy

Group B

ACTIVE COMPARATOR

Patients suffering from midfoot arthritis after failed prior conservative therapy who undergo a fusion of one or more midfoot (tarsometatarsal) joints

Procedure: tarsometatarsal fusion

Interventions

reverse distal metatarsal minimal-invasive osteotomyPROCEDURE

minimal-invasive oblique osteotomy of the two or three metatarsal bones using a straight burr

Group A
tarsometatarsal fusionPROCEDURE

open procedure with fusion and screw and plate fixation of two to three tarsometatarsal joints

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years
  • Midfoot arthritis of lesser TMTJ (second, third, rarely fourth and fifth) with ongoing disabling pain
  • Able to give informed consent as documented by signature
  • failed conservative treatment for a period of at least 3 months (CSI injections and/or orthotic devices)

You may not qualify if:

  • Concomitant fusion of 1st TMTJ
  • Patients younger than 18 years
  • Contraindication to undergo surgery or general anaesthesia
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Baden

Baden, Canton of Aargau, 5400, Switzerland

RECRUITING

Related Publications (3)

  • Gougoulias N, Lampridis V. Midfoot arthrodesis. Foot Ankle Surg. 2016 Mar;22(1):17-25. doi: 10.1016/j.fas.2015.04.004. Epub 2015 Apr 24.

    PMID: 26869495BACKGROUND

  • Laffenetre O, Perera A. Distal Minimally Invasive Metatarsal Osteotomy ("DMMO" Procedure). Foot Ankle Clin. 2019 Dec;24(4):615-625. doi: 10.1016/j.fcl.2019.08.011.

    PMID: 31653366BACKGROUND

  • Schneider TE, Varrall CR, Malhotra K. Early results of minimally invasive, reverse-oblique, distal metaphyseal metatarsal osteotomy (R-DMMO) for arthritis of the lesser tarsometatarsal joints - A retrospective case series. Foot (Edinb). 2020 Jun;43:101652. doi: 10.1016/j.foot.2019.10.007. Epub 2019 Oct 25.

    PMID: 32086136BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Karim Eid, PD Dr. med.

CONTACT

0564863062karim.eid@ksb.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 20, 2021

Study Start

May 14, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

May 20, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)