Muscle MRI Fat Fraction Before Surgery to Predict Strength Recovery After Foot-Drop Surgery in Charcot-Marie-Tooth Disease
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Source: NCT07894536, who can take part
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- Who runs it
- Peking University Third Hospital
- Trial code
- NCT07894536
- Record updated
- 26 October 2026
- Original description
The purpose of this prospective observational cohort study is to determine whether the amount of fat inside the donor muscles before surgery, measured with a magnetic resonance imaging (MRI) technique called Dixon fat fraction (FF), can predict how much ankle dorsiflexion strength patients with Charcot-Marie-Tooth disease (CMT) recover after tibialis posterior tendon transfer surgery.Read full original descriptionShow less
Preoperative Donor Muscle Fat Fraction Predicts Dorsiflexion Strength Recovery After Tibialis Posterior Tendon Transfer in Charcot-Marie-Tooth Disease
The purpose of this prospective observational cohort study is to determine whether the amount of fat inside the donor muscles before surgery, measured with a magnetic resonance imaging (MRI) technique called Dixon fat fraction (FF), can predict how much ankle dorsiflexion strength patients with Charcot-Marie-Tooth disease (CMT) recover after tibialis posterior tendon transfer surgery.
CMT is an inherited nerve disease that weakens the feet and legs, causing foot drop and high-arched, inwardly turned feet. A common operation transfers the tibialis posterior tendon to the top of the foot to restore foot lifting; however, the transplanted muscle itself may be weakened by fatty degeneration, and surgeons currently have no objective way to know in advance how well the transferred muscle will work.
We hypothesize that a lower preoperative fat fraction of the tibialis posterior (donor) muscle is associated with greater recovery of dorsiflexion strength after surgery.
A total of 100 adults (18-55 years) with genetically confirmed CMT types 1A, 1X or 2A who are scheduled for individualized foot surgery that includes tibialis posterior tendon transfer will be enrolled at 4 foot-and-ankle centers in China.
Within 1 month before surgery, participants will undergo a lower-leg MRI with a Dixon sequence to measure the fat fraction of 11 calf muscles. Participants will then be followed for 5 years (3 and 6 months, and 1, 2, 3, 4 and 5 years after surgery).
At every visit, ankle dorsiflexion strength will be measured with a hand-held dynamometer and normalized to body weight (newtons per kilogram); walking ability (1-minute walk distance, 10-meter walking speed), ankle range of motion, clinical severity scales (CMTES, Walk-12, FADI, SF-12) and CMT-related symptoms (pain, fatigue, cramps, balance and falls, sensory loss, hand function, brace use, calluses, mood) will also be assessed. Surgical details of every additional procedure will be recorded.
The primary analysis will correlate preoperative tibialis posterior fat fraction with the change in dorsiflexion strength at each time point (principal endpoint: 12 months), and will test whether fat fraction independently predicts strength recovery in a multivariable regression model.
If confirmed, preoperative muscle fat fraction could become an objective, readily available imaging marker to help surgeons select patients, choose between tendon transfer alternatives, and counsel patients about expected outcomes.
Inclusion: Age 18-55 years at enrollment, either sex; Genetically confirmed CMT1A (PMP22 17p11.2 duplication), CMT1X (GJB1 pathogenic variant) or CMT2A (MFN2 pathogenic variant), documented by a certified genetic testing report; Symptomatic flexible cavovarus (or planovarus) foot deformity with foot drop attributable to CMT; the planned surgery includes tibialis posterior tendon transfer for dorsiflexion augmentation with or without adjunct soft-tissue or bony procedures; Preoperative lower-leg MRI including a Dixon sequence of the index (first-operated) limb within 1 month (30 days) before surgery; Able to walk at least 10 m with or without ankle-foot orthosis (AFO) or a single cane; Able and willing to comply with the 5-year follow-up schedule and all assessments; Written informed consent obtained.
Exclusion: Prior corrective bony or tendon-transfer surgery on the index limb; Participation in another interventional study, or initiation/change of pharmacological treatment for CMT within 6 months before baseline with planned change during the study; Foot drop or cavovarus deformity attributable to causes other than CMT (e.g., traumatic peroneal nerve injury, lumbar radiculopathy, stroke/spasticity, hereditary spastic paraplegia, diabetic or other acquired neuropathies); Active infection or ulceration of the surgical field, Charcot neuroarthropathy, or severe peripheral vascular insufficiency; MRI contraindications (cardiac pacemaker/ICD, ferromagnetic implants, refractory claustrophobia, pregnancy); Comorbid conditions materially limiting gait or strength testing (advanced hip/knee osteoarthritis, symptomatic cardiopulmonary disease, other major neurological disease); Severe cognitive impairment precluding informed consent or reliable testing; Primary correction planned by hindfoot or midfoot arthrodesis (e.g., triple/double arthrodesis) or ankle arthrodesis/replacement.