NCT05736328

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

March 2, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

February 6, 2023

Last Update Submit

March 2, 2023

Conditions

Keywords

Neuro-OrthopaedicsTractionTenotomyDisabled persons

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Success of surgery

    At 30 days after surgery

  • Popliteal angle

    Daily, during the traction (up to 7 days).

  • Knee angle

    Daily, during the traction (up to 7 days).

  • Pain

    Daily, during the traction (up to 7 days).

  • Skin condition

    Daily, during the traction (up to 7 days).

Study Arms (1)

Subjects admitted for percutaneous needle tenotomy of the knee flexor muscles

Postoperative lower extremity traction.

Procedure: Traction

Interventions

TractionPROCEDURE

Postoperative lower extremity traction

Subjects admitted for percutaneous needle tenotomy of the knee flexor muscles

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP

Garches, 92380, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26624990BACKGROUND
  • 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.

    PMID: 29112966BACKGROUND
  • 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.

    PMID: 35843500BACKGROUND

MeSH Terms

Interventions

Traction

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • François Genêt, MD-PhD

    Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

    STUDY CHAIR
  • Vincent T. Carpentier, MD-MSc

    Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

    STUDY DIRECTOR

Central Study Contacts

François Genêt, MD-PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 21, 2023

Study Start

March 2, 2023

Primary Completion

January 31, 2024

Study Completion

February 28, 2024

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations