Clinical trial NCT05736328: Effect of Lower Extremity Traction on the Popliteal Angle After Percutaneous Needle Tenotomy of the Knee Flexor Muscles.
Official title: Effect of Lower Extremity Traction on the Popliteal Angle After Percutaneous Needle Tenotomy of the Knee Flexor Muscles.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disability or Chronic Disease Leading to Disablement
Keywords: Neuro-Orthopaedics
Traction
Tenotomy
Disabled persons
Lead sponsor: Institut de Sante Parasport Connecte Synergies
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2023-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with neuromotor disability and admitted for the treatment of limb deformities by percutaneous needle tenotomy of the knee flexor muscles.

Brief summary: People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at risk of neuro-orthopaedic disorders. Microinvasive percutaneous needle tenotomy is a frequent use alternative to open surgery to treat limb deformities. A lower extremity traction is performed in our unit during 2 to 7 days after surgery of the knee flexor muscles.

The aim of this study is to describe the efficiency of lower extremity traction on the popliteal angle after percutaneous needle tenotomy of the knee flexor muscles.

Detailed description: This is a prospective, monocentric, cohort study of neurological disabled inpatients subjects treated in the perioperative disability unit (UPOH) of our university hospital for limb deformities by percutaneous needle tenotomy of the knee flexor muscles.

All eligible inpatient subjects with neuromotor disability and admitted for the treatment of limb deformities by percutaneous needle tenotomy of the knee flexor muscles will be consecutively included.

Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological, and physiological examinations.

This is a routine care study; no procedures are added for research purposes. It is an ancillary study to the NO-AGING study.

Eligibility criteria: Inclusion Criteria:

* Patients \>= 18 years old ;
* Treated in the Perioperative Disability Unit (UPOH) of the Physical Medicine and Rehabilitation Department of our university hospital;
* Admitted for the treatment of limb deformities by percutaneous needle tenotomy of the knee flexor muscles ;
* Having a neuromotor disability;
* No opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it;
* Affiliation to a social security scheme.

Exclusion Criteria:

* Associated open surgery ;
* Associated bone surgery ;
* Under court protection.

Primary outcomes:
measure: Popliteal angle at the end of the traction
timeFrame: Daily, during the traction (up to 7 days).
Secondary outcomes:
measure: Success of surgery
timeFrame: At 30 days after surgery
measure: Popliteal angle
timeFrame: Daily, during the traction (up to 7 days).
measure: Knee angle
timeFrame: Daily, during the traction (up to 7 days).
measure: Pain
timeFrame: Daily, during the traction (up to 7 days).
measure: Skin condition
timeFrame: Daily, during the traction (up to 7 days).
Other outcomes:
Locations:
city: Garches
country: France
facility: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
name: François Genêt, MD-PhD
role: STUDY_CHAIR
affiliation: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
name: Vincent T. Carpentier, MD-MSc
role: STUDY_DIRECTOR
References:
citation: Chesnel C, Genet F, Almangour W, Denormandie P, Parratte B, Schnitzler A. Effectiveness and Complications of Percutaneous Needle Tenotomy with a Large Needle for Muscle Contractures: A Cadaver Study. PLoS One. 2015 Dec 1;10(12):e0143495. doi: 10.1371/journal.pone.0143495. eCollection 2015.
citation: Schnitzler A, Genet F, Diebold A, Mailhan L, Jourdan C, Denormandie P. Lengthening of knee flexor muscles by percutaneous needle tenotomy: Description of the technique and preliminary results. PLoS One. 2017 Nov 7;12(11):e0182062. doi: 10.1371/journal.pone.0182062. eCollection 2017.
citation: Angioni F, Salga M, Denormandie P, Genet F, Haigh O, David R, Gatin L, Schnitzler A. Microinvasive percutaneous needle tenotomy, An alternative to open surgery to treat neurological foot deformities. Ann Phys Rehabil Med. 2023 Mar;66(2):101690. doi: 10.1016/j.rehab.2022.101690. Epub 2022 Nov 30. No abstract available.