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

Recruiting

• Conditions: Disability or Chronic Disease Leading to Disablement

• Registration Number: NCT05736328
• Lead Sponsor: Institut de Sante Parasport Connecte Synergies

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.

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-21
• Status Verified: 2023-03
• Study Start: 2023-03-02
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03
• Primary Completion: 2024-01-31
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Popliteal angle at the end of the traction	Daily, during the traction (up to 7 days).	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.

Secondary Outcome Measures

Name	Time	Method
Pain	Daily, during the traction (up to 7 days).	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).
Skin condition	Daily, during the traction (up to 7 days).	Presence of erythema, phlyctens or superficial pressure sores
Popliteal angle	Daily, during the traction (up to 7 days).	Evaluated by goniometry or Kinovea
Knee angle	Daily, during the traction (up to 7 days).	Evaluated by goniometry or Kinovea
Success of surgery	At 30 days after surgery	Evaluated by the Goal Assessment Scale (GAS). Minimum and maximum values : -2 (worse outcome) / +2 (better outcome)

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP; 🇫🇷 Garches, France