A Comparative Trial of a Minimal-invasive Technique Versus Open Arthrodesis in the Treatment of Midfoot Arthritis

May 18, 2021 updated by: Christopher G Lenz, Kantonsspital Baden

Can Reverse Oblique Distal Minimal-invasive Osteotomies Replace Arthrodesis of the Tarsometatarsal Joints? - a Prospective, Comparative Trial of 50 Patients

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Midfoot arthritis is a common condition leading to disabling chronic foot pain that affects activities of daily living. The causes can be primary osteoarthritis (OA), inflammatory or post-traumatic. We are looking at OA of the lesser (second and/or third) tarsometatarasal joints (TMTJ). Orthotics, customised shoes or steroid injections are options to treat this condition nonoperatively. If these measures fail, arthrodesis of the arthritic joints represents the standard procedure to surgical treatment. Generally, the results of this procedure are at a satisfactory level for the patients, nevertheless, there is a relevant amount of patients with residual pain, lack of a normal foot appearance, and the need for unplanned surgery or use of orthotics postoperatively. Furthermore, patients undergoing an arthrodesis of the lesser TMTJ usually have to stay in hospital for 4-7 days. Postoperatively, patients are only allowed to partially weightbear for at least 6 weeks and need a cast for six weeks as well. During that time thrombosis prophylaxis is administered for about 6 weeks.

The conventional distal minimal-invasive metatarsal osteotomy (DMMO) is an accepted technique for metatarsal osteotomies. Recently, Schneider et al. presented results of a modification of the conventional DMMO, the reverse DMMO to treat OA of the lesser TMTJ, thus representing an alternative treatment to arthrodesis. The procedure has many benefits. It allows outpatient care, an immobilisation in a cast is not necessary. Instead, patients have to wear a flat postoperative shoe for 2-3 weeks and are allowed to fully weightbear from day one after surgery. Therefore, thrombosis prophylaxis is not necessary unless there are specific risk factors.

However, while the arthrodesis directly addresses the arthritic joints, the R-DMMO alters the ground reaction force of the metatarsal head leading to less stress at the level of the TMTJ, but the arthritic joint itself is not approached. Still, the results presented by Schneider et al. are promising. Since there was no group to compare the treatment with, the small sample size, and a retrospective design, we would like to prospectively compare these two surgical procedures directly in order to find out whether or not the R-DMMO can be recommended as a standard procedure for OA of the lesser TMTJ at a much more convenient level for patients regarding the whole perioperative protocol. No vulnerable population is included. The scientific value is remarkable since this would be the first study to examine this matter and we are able to provide a high level of evidence due to the prospective-randomised and comparative design of the study. All legal requirements will be fulfilled and the ethical standards are guaranteed.

Both procedures have been described and the technique of the DMMO itself is not new, but its modification (R-DMMO) represents a new approach for this condition. Both procedures are reliable and safe, which is why the risk category of the study is A according to ClinO, Art. 61.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • Aargau
      • Baden, Aargau, Switzerland, 5400
        • Recruiting
        • Kantonsspital Baden
        • Contact:
        • Principal Investigator:
          • Christopher G Lenz, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
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
minimal-invasive oblique osteotomy of the two or three metatarsal bones using a straight burr
Active Comparator: Group B
Patients suffering from midfoot arthritis after failed prior conservative therapy who undergo a fusion of one or more midfoot (tarsometatarsal) joints
Procedure: tarsometatarsal fusion
open procedure with fusion and screw and plate fixation of two to three tarsometatarsal joints

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 weeks, 3 months, 6 months, 12 and 24 months post surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of procedure
Time Frame: through study completion, an average of 2 years
Duration of procedure (in minutes from first incision until wound is closed)
through study completion, an average of 2 years
Length of hospital stay
Time Frame: through study completion, an average of 2 years
Length of hospital stay in days
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.
Time Frame: 6 weeks, 3 months, 6 months, 12 and 24 months post surgery
Pain score (scale 0-10, where 10 is the maximum pain)
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.
Time Frame: 6 weeks, 3 months, 6 months, 12 and 24 months post surgery
Union of bone on conventional X-Ray in two planes (dorsoplantar and lateral views)
6 weeks, 3 months, 6 months, 12 and 24 months post surgery
Complications
Time Frame: 6 weeks, 3 months, 6 months, 12 and 24 months post surgery
Identifying minor and major complications of the procedure (e.g. infections)
6 weeks, 3 months, 6 months, 12 and 24 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Baden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-00916

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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