OsteoarthritisNCT04894578
A Comparative Trial of a Minimal-invasive Technique Versus Open Arthrodesis in the Treatment of Midfoot Arthritis
A study testing reverse distal metatarsal minimal-invasive osteotomy and tarsometatarsal fusion in people with Osteoarthritis and Foot, run by Kantonsspital Baden at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Foot, Osteotomy
- What is being tested?
- reverse distal metatarsal minimal-invasive osteotomy and tarsometatarsal fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 May 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Baden
Baden, Canton of Aargau, 5400
Karim Eid, PD Dr. med., 0041564862888, karim.eid@ksb.ch
Christopher G Lenz, Dr. med.
About this study
Official title: 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
Read the 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
- Being tested
- reverse distal metatarsal minimal-invasive osteotomy, tarsometatarsal fusion
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reverse distal metatarsal minimal-invasive osteotomyProcedure or surgery
minimal-invasive oblique osteotomy of the two or three metatarsal bones using a straight burr
tarsometatarsal fusionProcedure or surgery
open procedure with fusion and screw and plate fixation of two to three tarsometatarsal joints
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients suffering from midfoot arthritis after failed prior conservative therapy who undergo a reverse distal metatarsal minimal-invasive osteotomy Receives: 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 Receives: Procedure: tarsometatarsal fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks, 3 months, 6 months, 12 and 24 months post surgery
Secondary outcomes (5)
Duration of procedure
Duration of procedure (in minutes from first incision until wound is closed)
Measured: through study completion, an average of 2 years
Length of hospital stay
Length of hospital stay in days
Measured: 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.
Pain score (scale 0-10, where 10 is the maximum pain)
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.
Union of bone on conventional X-Ray in two planes (dorsoplantar and lateral views)
Measured: 6 weeks, 3 months, 6 months, 12 and 24 months post surgery
Complications
Identifying minor and major complications of the procedure (e.g. infections)
Measured: 6 weeks, 3 months, 6 months, 12 and 24 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start14 May 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher G Lenz, Kantonsspital Baden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894578
- Sponsor's protocol ID
- 2020-00916
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26869495Laffenetre 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.
PubMed 31653366Schneider 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.
PubMed 32086136
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Reverse Oblique Distal Minimal-invasive Osteotomies Replace Arthrodesis of the Tarsometatarsal Joints? - a Prospective, Comparative Trial of 50 Patients
- ClinicalTrials.gov ID
- NCT04894578
- Acronym / sponsor ID
- 2020-00916
- Conditions
- Osteoarthritis, Foot, Osteotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kantonsspital BadenUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: reverse distal metatarsal minimal-invasive osteotomyPatients suffering from midfoot arthritis after failed prior conservative therapy who undergo a reverse distal metatarsal minimal-invasive osteotomy |
| Group B | Active comparator | Procedure: tarsometatarsal fusionPatients suffering from midfoot arthritis after failed prior conservative therapy who undergo a fusion of one or more midfoot (tarsometatarsal) joints |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reverse distal metatarsal minimal-invasive osteotomyminimal-invasive oblique osteotomy of the two or three metatarsal bones using a straight burr | Procedure or surgery | Group A |
| tarsometatarsal fusionopen procedure with fusion and screw and plate fixation of two to three tarsometatarsal joints | Procedure or surgery | Group B |
Primary outcome
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
5 secondary outcomes
Duration of procedure
Time frame: through study completion, an average of 2 years
Length of hospital stay
Time frame: 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
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
Complications
Time frame: 6 weeks, 3 months, 6 months, 12 and 24 months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Background: PubMed 26869495Gougoulias 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.
- Background: PubMed 31653366Laffenetre 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.
- Background: PubMed 32086136Schneider 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reverse distal metatarsal minimal-invasive osteotomy and tarsometatarsal fusion in people with Osteoarthritis and Foot, run by Kantonsspital Baden at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karim Eid, PD Dr. med. (0564863062, karim.eid@ksb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894578, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.