Disability or Chronic Disease Leading to DisablementNCT05736328
Effect of Lower Extremity Traction on the Popliteal Angle After Percutaneous Needle Tenotomy of the Knee Flexor Muscles.
An observational study of Disability or Chronic Disease Leading to Disablement, run by Institut de Sante Parasport Connecte Synergies at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disability or Chronic Disease Leading to Disablement
- What is being tested?
- Traction
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2023to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects with neuromotor disability and admitted for the treatment of limb deformities by percutaneous needle tenotomy of the knee flexor muscles.
Who may be able to join
- 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.
Who cannot join
- Associated open surgery ;
- Associated bone surgery ;
- Under court protection.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
Garches, 92380
Vincent T Carpentier
François Genêt
About this study
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.
Read the 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.
- Being tested
- Traction
- Keywords
- Neuro-Orthopaedics, Traction, Tenotomy, Disabled persons
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TractionProcedure or surgery
Postoperative lower extremity traction
| Study group | Role | What they receive |
|---|---|---|
| Subjects admitted for percutaneous needle tenotomy of the knee flexor muscles | Postoperative lower extremity traction. Receives: Procedure: Traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily, during the traction (up to 7 days).
Secondary outcomes (5)
Success of surgery
Evaluated by the Goal Assessment Scale (GAS). Minimum and maximum values : -2 (worse outcome) / +2 (better outcome)
Measured: At 30 days after surgery
Popliteal angle
Evaluated by goniometry or Kinovea
Measured: Daily, during the traction (up to 7 days).
Knee angle
Evaluated by goniometry or Kinovea
Measured: 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).
Measured: Daily, during the traction (up to 7 days).
Skin condition
Presence of erythema, phlyctens or superficial pressure sores
Measured: Daily, during the traction (up to 7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start2 Mar 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disability or Chronic Disease Leading to DisablementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Sante Parasport Connecte Synergies
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- François Genêt, MD-PhD, Study chair, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, FranceVincent T. Carpentier, MD-MSc, Study director, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736328
- Sponsor's protocol ID
- 2023-002
- Status last verified
- Mar 2023
- First submitted
- 6 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26624990Schnitzler 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.
PubMed 29112966Angioni 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.
PubMed 35843500
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lower Extremity Traction on the Popliteal Angle After Percutaneous Needle Tenotomy of the Knee Flexor Muscles.
- ClinicalTrials.gov ID
- NCT05736328
- Acronym / sponsor ID
- 2023-002
- Keywords
- Neuro-Orthopaedics, Traction, Tenotomy, Disabled persons
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institut de Sante Parasport Connecte SynergiesUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects admitted for percutaneous needle tenotomy of the knee flexor muscles | – | Procedure: TractionPostoperative lower extremity traction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects with neuromotor disability and admitted for the treatment of limb deformities by percutaneous needle tenotomy of the knee flexor muscles.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- Associated open surgery ;
- Associated bone surgery ;
- Under court protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TractionPostoperative lower extremity traction | Procedure or surgery | Subjects admitted for percutaneous needle tenotomy of the knee flexor muscles |
Primary outcome
Popliteal angle at the end of the traction
Time frame: 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.
5 secondary outcomes
Success of surgery
Time frame: At 30 days after surgery
Popliteal angle
Time frame: Daily, during the traction (up to 7 days).
Knee angle
Time frame: Daily, during the traction (up to 7 days).
Pain
Time frame: Daily, during the traction (up to 7 days).
Skin condition
Time frame: Daily, during the traction (up to 7 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Background: PubMed 26624990Chesnel 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.
- Background: PubMed 29112966Schnitzler 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.
- Background: PubMed 35843500Angioni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Genêt, MD-PhD study chair
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
Vincent T. Carpentier, MD-MSc study director
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disability or Chronic Disease Leading to Disablement, run by Institut de Sante Parasport Connecte Synergies at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Genêt, MD-PhD (+ 33 1 47 10 70 82, françois.genet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Popliteal angle at the end of the traction (time frame: Daily, during the traction (up to 7 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05736328, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.