Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Midfoot Osteotomy, 8-Plate Epiphysiodesis.
- Who it may be relevant to
- Registry conditions: Club Foot. Basic parameters: 4 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus in Relapsed Congenital Talipes Equinovarus
Overview
Epiphysiodesis
Detailed description
Congenital Talipes Equinovarus (CTEV) is a significant musculoskeletal deformity affecting children globally. It is characterized by hindfoot varus, midfoot cavus, forefoot adduction, and ankle equines (1). The Ponseti method has proven to be highly effective and is now the gold standard for treatment. However, long-term follow-up studies indicate a variable relapse rate. Timely diagnosis of relapse is crucial, underscoring the importance of regular follow-up visits (2).
Nowadays the method has replaced the surgery and served as the gold standard for the treatment of congenital clubfoot in pediatric orthopedics(3) . However, it is still challenging to treat severe cases such as neglected or relapsed clubfoot in older children(4). Among the deformities, residual forefoot adduction with supination after treatment is a common issue which is also referred to as the "bean-shaped foot"( 5) . According to Jasiewicz et.al study, the combination of a cuboid closing with a cuneiform opening wedge osteotomy or with a trans-midfoot osteotomy is currently the most popular procedure to correct the residual forefoot adduction(6).
However, complications such as neurovascular lesion, non-union or permanent foot stiffness might occur as a result of the operation. In addition, the tarsal growth plate and cartilaginous area could be compromised due to the difficulty in manipulating the osteotomy and fixation process(7). 8-plate is one of the major methods that gained popularity quickly due to temporary growth impediment of the physis without damaging it irreversibly, and is suitable for a variety of indications including different plane deformities around the knee and limb length discrepancies(8). However, there are a few reports regarding 8-plates in individuals with clubfoot deformities. Recently, guided growth techniques using temporary epiphysiodesis (8 -plate) have been introduced as a minimally invasive alternative that allows gradual correction by modulating growth.However, high-quality comparative clinical evidence between these two techniques is lacking.
The current research is the first one to compare the clinical, radiological, and patient satisfaction outcome of midfoot osteotomy versus eight -Plate epiphysiodesis for residual metatarsal adductus in relapsed clubfoot.The purpose of this prospective study is to show the best technique to achieve patient satisfaction.
Interventions
- Procedure Midfoot Osteotomy
Group 1 Immobilization in along leg (above knee cast) for 6 weeks Non-weight bearing during casting period Cast removal followed by gradual return to weight bearing - Procedure 8-Plate Epiphysiodesis
NO immobilization, only protective splinting for 2 weeks as postoperative rest, after splint removal return to normal activity. Plate will be removed after full clinical and radiological correction. Further procedures e.g. tibalis anterior tendon transfer can be done as needed.
Primary outcome measures
- To compare the results of the two technical procedures of surgical treatment by Radiological correction [Time frame: 6 months after surgery]
Eligibility criteria
Inclusion criteria
- Patients are eligible for participation in the study if
- Age between 5 to 10 years old
- Relapsed idiopathic clubfoot (CTEV)
- Presence of residual metatarsal adductus
Exclusion criteria
- Patients are excluded for participation in the study if
- Teratologic clubfoot (e.g., myelomeningocele).
- Children under 4 years of mild severity that could be corrected with conservative treatment, or above 10 years old.
- flexible (correctable) deformity of the foot.
- Cases recurrent after midtarsal osteotomy
- Neuromuscular CTEV, or arthrogryposis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Zhao H, Ruan H, Cao Y, Yuan H, Kang Q. Outcomes of Eight-Plate Epiphysiodesis for Residual Clubfoot Deformities. Orthop Surg. 2022 Dec;14(12):3417-3422. doi: 10.1111/os.13548. Epub 2022 Oct 17. PMID 36254364
Identifiers
NCT: NCT07466043 · orthopedic