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NCT Number: NCT06477315

Mid- and Long-term Evaluation of the Results of Patients Undergoing Spinal Cord Stimulation With Microfractures + BST CarGel in the Treatment of Patellofemoral Chondral Lesions of the Knee

The study consists of 3 phases (Identification of eligible patients, follow-up by telephone or telemedicine platform and the collection of study-specific clinical data of enrolled patients):

* Identification by trained medical personnel of subjects who meet the study inclusion criteria. * Once the patient's Informed Consent has been obtained, the study-specific questionnaires will be submitted. * Clinical score data will be collected from the questionnaires conducted at mid- and long-term follow-up of patients enrolled in the study. The data collected during the long-term follow-up will be used to evaluate the time course of the results obtained after treatment of osteochondral lesions of the patellar cartilage by spinal cord stimulation with microfractures

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chondral Lesion of the Knee Patellofemoral Disorder

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients, aged between 18 and 75 years;
  • BMI up to 30 kg/m2;
  • Patients without subsequent surgery on the patellofemoral cartilage of the knee undergoing treatment;
  • Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;
  • Signature of informed consent
  • availability
  • Competent patients

Exclusion criteria

  • Patients no longer available;
  • Patients who do not agree to undergo assessment;
  • Deceased patients

Treatment and study plan

Survey

Other

telephone surveys

Primary outcomes

  1. International Knee Documentation Committee

    Time frame: baseline (post surgery)

    This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. The questionnaire examines 3 categories: symptoms, sports activity and knee function. According to this questionnaire, a score between 0 and 100 can be obtained, whereby a high score is associated with a high level of function and minor pain symptoms. A score of 100 is in fact interpreted as a condition in which there are neither limitations in conducting activities of daily living nor symptoms.

  2. Knee Injury and Osteoarthritis Outcome Score

    Time frame: baseline (post surgery)

    The complete questionnaire consists of five subscales and covers: pain (9 items), symptoms (7 items of which two concern stiffness), functions and activities of daily living (17 items) physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). All items of the relevant subscales have the same response mode, use a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no difficulty" and 4 "severe difficulty".) Score range 0-100 for each subscale.

  3. EuroQol visual analogue scale

    Time frame: baseline (post surgery)

    It is a visual analogue scale that has a range of scores between 0 (worst imaginable health condition) and 100 (best imaginable health condition).

  4. Tegner Score

    Time frame: baseline (post surgery)

    allows one to estimate the motor activity level of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as football at national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders.

  5. (EuroQoL) Current Health Assessment

    Time frame: baseline (post surgery)

    valuable tool for measuring a patient's quality of life

  6. Patient Acceptable Symptom State

    Time frame: baseline (post surgery)

    Valuable tool for assessing patient satisfaction in view of their current degree of pain, function and daily activity

  7. Final assessment of treatment

    Time frame: baseline (post surgery)

    The patient should indicate satisfaction and the relative degree of satisfaction with the treatment after a minimum of 5 years after the infiltrative treatment.

  8. failure question

    Time frame: baseline (post surgery)

    the patient should indicate whether and when a new infiltrative or surgical treatment was performed. Questions will also be asked about possible complications and re-interventions

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: CARGEL-LT

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jun 27, 2024
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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