Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail

Leg Length Inequality Clinical Trial

— FitForFrance  

Official title:

Prospective, Observational Study to Assess the Pain, Satisfaction, and Quality of Life of Patients Implanted With the FITBONE® Lengthening Nail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06156384
• Other study ID #: OCI_2301
• Secondary ID: 2023-A02702-43
• Status: Recruiting
• Start date: June 18, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: June 2024
• Source: Orthofix s.r.l.
• Contact: Edo Knijff
• Phone: +390456719000
• Email: EdoKnijff[@]orthofix.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a prospective observational non-interventional multi-centre cohort study of patients, 12 years or older, initiating a lower limb lengthening procedure with FITBONE and who have a length discrepancy of 30mm or more between the limbs.

The following parameters will be assessed for up to 24 months.

• Pain using the Visual Analog Scale (VAS), Patient Global Assessment (PGA) and Clinical Observer Global Assessment (COGA)

• Patient satisfaction using the Patient Global Impression of change (PGI-C) scale

• QoL using the 36-Item Short Form Survey/Paediatric Quality of Life Inventory (SF-36/PedsQL)

Description:

The study period is 24 months post-surgery. Each patient's demographic data, medical history, any relevant concomitant medication, physical examination, range of motion data will be recorded using a standardized case record form after informed consent is provided and the healthcare provider completes a physical examination regarding the patient's conditions and record determination as to whether FITBONE is recommended. The decision to treat, observe, and to include in this observation study is at the discretion of the healthcare provider. This is an observational study and therefore, the participating healthcare provider will manage patients according to the usual clinical practice.

Surgery will be performed according to the standard surgical procedure described previously. Study of Investigational Product(s). Five to ten days after the lengthening nail placement, the lengthening mechanism is operated by transmitting energy necessary for the lengthening from the outside. This period is referred to as the distraction period. The rhythm of lengthening and strict protocol for an individual patient, indicating the daily lengths of lengthening to be applied, are decided by the healthcare provider taking into account all influencing factors. Therefore, the end of the distraction period, bone healing, implant removal, and 6 months post-implant removal may differ by individual. In the event the distraction period is extended by the healthcare provider, the new distraction period will determine the end of the distraction time point. All patients will be followed until the end of the scheduled study period regardless of any change in their treatment or other conditions.

Six visits are planned:

1. Surgery (baseline)

2. End of the distraction phase

3. End of bone healing

4. Implant removal

5. 6-month post-removal

6. 24-month post-surgery The satisfaction will be assessed at implant removal, 6 months post implant removal, and 24 months post-surgery.

The QoL will be assessed at baseline, at 6 months post implant removal, and 24 months post-surgery.

Pain will be assessed at all timepoints. Measurement of pain at the end of the distraction phase, the patient will be requested to report the pain experienced in the past week, at the moment, and during or immediately after the distraction period. At other time points, pain for only at the moment will be captured.

Range of motion (ROM) will be measured at the end of bone healing, and at the 24 months post-surgery.

Lengthening achieved will be measured at the end of bone healing. Any incidence of adverse events will be recorded at any point during the 24-month follow-up period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patients aged =12 years old, with congenital or acquired lower limb discrepancy greater than 30mm, undergoing femoral or tibia bone lengthening with FITBONE

• Patients with a regular indication for a surgical intervention with FITBONE according to manufacturer IFU

• The patient (or his/her legally acceptable representative) is capable of understanding the content of the Informed Consent Form (ICF)

• The informed consent form is correctly obtained

Exclusion Criteria:

• Patients with a medical condition that is contraindicated according to the FITBONE instruction for use.

• Patients with any conditions that, in the Investigator's opinion, may interfere with the study execution, including those likely to be lost to follow-up.

• Patients who have any conditions or medical condition that, in the investigator's opinion, may interfere with the study's execution or in which the patient should not participate for safety reasons.

• Patients requiring the application of or have already in-situ concomitant devices that cannot be safely removed (except for permitted concomitant devices).

• Patients participating in other clinical or have taken part in any clinical study in the last 3 months.

Related Conditions & MeSH terms

• Leg Length Inequality

Intervention

Device:
• FITBONE® Lengthening Nail
The patient is installed on a standard orthopaedic table, intramedullary reaming is performed through a metal working tube. The osteotomy is performed percutaneously and then an osteotome according to the postage-stamp technique. Once the FITBONE lengthening nail is placed in the desired location, it should be connected to the subcutaneous receiver. The receiver should be placed close enough to the skin surface to ensure the energy transfer from the external transmitter. After 5 to 10 days after surgery, the lengthening mechanism is operated by the patient, using the transmitter. An elongation of approximately 1 mm/day takes place. The attending physician determines the rhythm of lengthening in each case. When the desired elongation length is reached, the consolidation phase begins, which is necessary for bone regeneration. The FITBONE lengthening nail can be removed once the bone has consolidated, approximately one to one and a half years after implantation.

Locations

Country	Name	City	State
France	CHU Lille - Hôpital Jeanne de Flandre	Lille	Hauts-de-France
France	Hôpital Sainte-Marguerite AP-HM	Marseille	Provence-Alpes-Côte d'Azur
France	CHU de La Réunion site Sud Saint-Pierre	Saint-Pierre	La Réunion
France	Centre hospitalier universitaire (CHU) de Toulouse	Toulouse	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
Orthofix s.r.l.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe Patients' Pain by Visual Analog Scale (VAS)	Pain will be measured by the Pain by Visual Analog Scale (VAS), performed by the patient, through the Patient Global Evaluation Assessment and by the physician (Clinical Observer Global Assessment). The VAS for pain ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain.	at implant removal date and at 24 months follow-up
Primary	Describe Patients' satisfaction	A dedicated patients satisfaction questionnaire has been developed with key opinion leaders (KOLs) and expert groups on the limb leg discrepancy treatment. The satisfaction questionnaire is made of 5 questions, for each question the patient have to reply using the Patient Global Impression of change ranging from 1 to 7, with 1 representing "Very much improved" to 7 being "Very much worse".	at implant removal date and at 24 months follow-up
Primary	Describe Patients' patient Quality of Life (QoL) using Short Form 36 Health Survey (SF-36) for adult patients and PedsQL (Pediatric Quality of Life Inventory) Generic Core Scale for children patients.	The Quality of Life (QoL) will be measured by the Short Form 36 Health Survey (SF-36) or PedsQL (Pediatric Quality of Life Inventory) Generic Core Scale, depending on the patient's age at enrolment: SF-36 for adults and PedsQl for children. Short Form 36 Health Survey has two components: Physical Component Summary (PCS) Minimum 0, Maximum 100; Mental Component Summary (MCS) Minimum 0, Maximum 100. Higher scores on both the Physical and Mental Component Summary scales indicate a better outcome, reflecting better health-related quality of life. The PedsQL Generic Core Scales are scored on a scale of 0 to 100, with higher scores indicating better health-related quality of life and 0 represents the worst health-related quality of life.	at implant removal date and at 24 months follow-up
Secondary	Monitor the clinical safety of Fitbone by collecting and characterizing the complications, expressed as adverse events and device deficiencies, associated with FITBONE	The clinical safety of Fitbone will be measured Collecting and characterizing the complications (expressed as adverse events and device deficiencies) associated with FITBONE that will be assessed by the investigators.	from surgery to 24 months follow-up
Secondary	Effectiveness of Fitbone by limb lengthening	The lengthening goal is considered 'achieved' when, at the end of bone healing, the limb length is within 5 mm of the lengthening objective defined by the investigator when using FITBONE.	at the end of bone healing, approximately 6 months
Secondary	Assess satisfaction evolution at implant removal , 6 months after Fitbone removal and at 24 months after surgery	A dedicated patients satisfaction questionnaire has been developed with key opinion leaders (KOLs) and expert groups on the limb leg discrepancy treatment. The satisfaction questionnaire is made of 5 questions, for each question the patient have to reply using the Patient Global Impression of change ranging from 1 to 7, with 1 representing "Very much improved" to 7 being "Very much worse".	from surgery to 24 months follow-up
Secondary	Describe evolution of QoL at 6 months after Fitbone removal and at 24 months after surgery, compared to baseline	The Quality of Life (QoL) will be measured by the Short Form 36 Health Survey (SF-36) or PedsQL (Pediatric Quality of Life Inventory) Generic Core Scale, depending on the patient's age at enrolment: SF-36 for adults and PedsQl for children. Short Form 36 Health Survey has two components: Physical Component Summary (PCS) Minimum 0, Maximum 100; Mental Component Summary (MCS) Minimum 0, Maximum 100. Higher scores on both the Physical and Mental Component Summary scales indicate a better outcome, reflecting better health-related quality of life. The PedsQL Generic Core Scales are scored on a scale of 0 to 100, with higher scores indicating better health-related quality of life and 0 represents the worst health-related quality of life.	from surgery to 24 months follow-up
Secondary	Describe pain at each visit using VAS	Pain will be measured by the Pain by Visual Analog Scale (VAS), performed by the patient, through the Patient Global Evaluation Assessment and by the physician (Clinical Observer Global Assessment). The VAS for pain ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain.	from surgery to 24 months follow-up
Secondary	Describe patients Range Of Motion (ROM in degrees) evolution at end of bone healing and at 24 months after surgery compared to baseline	The knee range of motion will measured in degree Difference in the range of motion through the passive extension before surgery (baseline) to the end of bone healing, and at 24 months post-surgery	from surgery to 24 months follow-up