Effect of Lower Extremity Traction on the Popliteal Angle After Percutaneous Needle Tenotomy of the Knee Flexor Muscles.
1 other identifier
observational
20
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2023
Shorter than P25 for all trials
1 active site
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
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
March 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedMarch 3, 2023
March 1, 2023
11 months
February 6, 2023
March 2, 2023
Conditions
Keywords
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.
Interventions
Postoperative lower extremity traction
Eligibility Criteria
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
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: 26624990BACKGROUNDSchnitzler 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: 29112966BACKGROUNDAngioni 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
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
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