Osteoarthritis Clinical Trial
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
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Kantonsspital Baden | Baden | Aargau |
Lead Sponsor | Collaborator |
---|---|
Kantonsspital Baden |
Switzerland,
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. — View Citation
Laffenêtre 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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Duration of procedure | Duration of procedure (in minutes from first incision until wound is closed) | through study completion, an average of 2 years | |
Secondary | Length of hospital stay | Length of hospital stay in days | through study completion, an average of 2 years | |
Secondary | 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) | 6 weeks, 3 months, 6 months, 12 and 24 months post surgery | |
Secondary | 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) | 6 weeks, 3 months, 6 months, 12 and 24 months post surgery | |
Secondary | Complications | Identifying minor and major complications of the procedure (e.g. infections) | 6 weeks, 3 months, 6 months, 12 and 24 months post surgery |
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