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

NCT ID: NCT04894578

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-14
• Study Completion Date: 2024-12-31

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

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.

Conditions

Osteoarthritis; Foot; Osteotomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

reverse distal metatarsal minimal-invasive osteotomy

Intervention Type: PROCEDURE

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

Group B

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

Group Type: ACTIVE_COMPARATOR

tarsometatarsal fusion

Intervention Type: PROCEDURE

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

Interventions

reverse distal metatarsal minimal-invasive osteotomy

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

Intervention Type: PROCEDURE

tarsometatarsal fusion

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kantonsspital Baden

OTHER

Sponsor Role: lead

Responsible Party

Christopher G Lenz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kantonsspital Baden

Baden, Canton of Aargau, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Karim Eid, PD Dr. med.

Role: CONTACT

karim.eid@ksb.ch

0564863062

Facility Contacts

Karim Eid, PD Dr. med.

Role: primary

karim.eid@ksb.ch

0041564862888

References

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.

Reference Type: BACKGROUND

PMID: 26869495 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31653366 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32086136 (View on PubMed)

Other Identifiers

2020-00916

Identifier Type: -

Identifier Source: org_study_id