Effect of Lower Extremity Traction on the Popliteal Angle After Percutaneous Needle Tenotomy of the Knee Flexor Muscles.

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.

Study Overview

• Status: Recruiting
• Conditions: Disability or Chronic Disease Leading to Disablement
• Intervention / Treatment: Procedure: Traction

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
    • Sub-Investigator: Marjorie Salga
    • Contact: Vincent T Carpentier
    • Sub-Investigator: Laure Gatin
    • Sub-Investigator: Sylvain Petit
    • Sub-Investigator: Fabien Calé
    • Sub-Investigator: Bernard Hollier-Larousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects admitted for percutaneous needle tenotomy of the knee flexor muscles; Postoperative lower extremity traction.	Procedure: Traction; Postoperative lower extremity traction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Popliteal angle at the end of the traction	Difference in popliteal angle between the beginning and end of traction, evaluated with the Kinovea angle measurement tool. In case of bilateral traction, the average of the differences of each limb will be considered.	Daily, during the traction (up to 7 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of surgery	Evaluated by the Goal Assessment Scale (GAS). Minimum and maximum values : -2 (worse outcome) / +2 (better outcome)	At 30 days after surgery
Popliteal angle	Evaluated by goniometry or Kinovea	Daily, during the traction (up to 7 days).
Knee angle	Evaluated by goniometry or Kinovea	Daily, during the traction (up to 7 days).
Pain	Numeric scale or Algoplus according to disability. Minimum and maximum values for the Numeric scale : 0 (no pain) / 10 (worst pain). Minimum and maximum values for the Algoplus scale : 0 (no pain) / 5 (worst pain).	Daily, during the traction (up to 7 days).
Skin condition	Presence of erythema, phlyctens or superficial pressure sores	Daily, during the traction (up to 7 days).

Collaborators and Investigators

• Sponsor: Institut de Sante Parasport Connecte Synergies
• Collaborators: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: François Genêt, MD-PhD, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France; Study Director: Vincent T. Carpentier, MD-MSc, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

Publications and helpful links

General Publications

• 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.
• 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.
• 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. 2022 Nov 30;66(2):101690. doi: 10.1016/j.rehab.2022.101690. Online ahead of print. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2023
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Traction; Disabled persons; Tenotomy; Neuro-Orthopaedics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 2023-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No