Management of Spastic Elbow Deformities

Overview

About this study

The purpose of this study is to evaluate the effectiveness of muscle-tendon lengthening procedures versus Hyperselective neurectomy (HSN) in decreasing elbow flexor spasticity and improving upper extremity function.

Surgical management to alleviate upper limb spasticity traditionally rely on lengthening the muscle-tendon units which often require a period of joint immobilization and extensive post-operative rehabilitation. HSN is an innovative procedure with early clinical evidence that has been shown to disrupt the heightened neural reflex arc that causes upper limb spasticity without the need for any post-operative rehabilitation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Inclusion criteria consists of patients (≥ 18 years old) with predominant spasticity (MAS ≥ 2) in their elbow flexors without a severely fixed joint contracture (≤ 30 degrees of flexion deformity) as a result of an acquired brain injury (cerebrovascular accident, anoxic brain injury, traumatic brain injury).
Adult patients (≥ 18 years) who are at least 12 months from their neurologic insult without evidence of ongoing neurorecovery will be placed into the muscle-tendon lengthening versus HSN group. Patients will be randomized to either study group with 16 patients in each cohort.

Exclusion Criteria:

Patients < 18 years of age.
Patients who are not medically optimized to undergo surgery.
Patients who cannot participate in the pre-operative electrophysiologic and gait analysis.
Patients who are on chronic anticoagulation that cannot be held perioperatively.

Eligibility last updated 11/12/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Peter Rhee, D.O., M.S.	Closed-enrolling by invitation What is this? (?) "Close" Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.	Contact information: Paul Cox (507) 538-3561 Cox.Paul@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Peter Rhee, D.O., M.S.

Closed-enrolling by invitation

Contact information:

Paul Cox

(507) 538-3561

Cox.Paul@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials