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

Disability or Chronic Disease Leading to Disablement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736328
• Other study ID #: 2023-002
• Status: Recruiting
• Start date: March 2, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2023
• Source: Institut de Sante Parasport Connecte Synergies
• Contact: François Genêt, MD-PhD
• Phone: + 33 1 47 10 70 82
• Email: françois.genet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 28, 2024
• Est. primary completion date: January 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Disability or Chronic Disease Leading to Disablement

Intervention

Procedure:
• Traction
Postoperative lower extremity traction

Locations

Country	Name	City	State
France	Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Sante Parasport Connecte Synergies	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Popliteal angle	Evaluated by goniometry or Kinovea	Daily, during the traction (up to 7 days).
Secondary	Knee angle	Evaluated by goniometry or Kinovea	Daily, during the traction (up to 7 days).
Secondary	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).
Secondary	Skin condition	Presence of erythema, phlyctens or superficial pressure sores	Daily, during the traction (up to 7 days).