ACL Clinical Trial
— LivD_ACLROfficial title:
A Prospective Cohort Study of Skeletally Immature Patients Requiring Endoscopic Anterior Cruciate Ligament Reconstruction, Using Living Donor Hamstring Allograft From a Parent
The Anterior Cruciate Ligament (ACL) is a major stabiliser of the knee. ACL rupture is being increasingly identified in children and skeletally immature patients. The current advice in younger patients is usually to undergo ACL reconstruction. The choice of an ideal graft in children is difficult This study will use a technique involves the use of hamstring tendons from a living donor, where the adult (usually a parent) agrees to donate their hamstring tendons, which are dissected out of them and implanted into the child
Status | Recruiting |
Enrollment | 10 |
Est. completion date | September 2028 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility | Inclusion Criteria: - Patients aged 8 to 17 years inclusive and have a clinically and radiologically confirmed ACL rupture that requires reconstruction. - Patients who have had previous surgery for meniscal pathology . - Patients with current meniscal pathology - The child and their responsible adult are in agreement with the choice to undergo anterior cruciate ligament reconstruction using living donor allograft. - Donors has not previously undergone tendon harvest on the chosen donor limb - Patients are willing to attend follow up appointments and agree to fill in knee questionnaires and allow instrumented knee ligament testing. Exclusion Criteria: - Patients who have previously undergone ACL surgery on the same limb (and therefore require revision surgery) - Patients who are immunosuppressed, or receiving immunosuppressive therapy - Patients who are unable to attend follow-up appointments for continued research purposes. - Donors who have previously undergone hamstring tendon surgery on the donor limb - Patients and donors who have a positive screening blood test for any of the transmissible infections tested - Donors whose answers to the 'Donor Documentation Questionnaire' indicate that there could be a risk of transmissible infection, may not included - Donors who are not considered healthy enough to undergo a tenotomy under General anaesthetic |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Trauma & Orthopaedic Dept, Tunbridge Wells Hospital | Pembury | Kent |
Lead Sponsor | Collaborator |
---|---|
Maidstone & Tunbridge Wells NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | International Knee Documentation Committee Subjective Knee Form (IKDC) | Evaluates symptoms, daily activity and sports function. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | 6 weeks post op | |
Primary | International Knee Documentation Committee Subjective Knee Form (IKDC) | Evaluates symptoms, daily activity and sports function. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | 6 months post op | |
Primary | International Knee Documentation Committee Subjective Knee Form (IKDC) | Evaluates symptoms, daily activity and sports function | 1 year post op | |
Primary | International Knee Documentation Committee Subjective Knee Form (IKDC) | Evaluates symptoms, daily activity and sports function. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | 2 years post op | |
Primary | Tegner Lysholm | Symptom reporting questionnaire made up of two components. The Lysholm score Scores range from 0 (worse disability) to 100 (less disability) and the Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer. | 6 weeks post op | |
Primary | Tegner Lysholm | Symptom reporting questionnaire made up of two components. The Lysholm score Scores range from 0 (worse disability) to 100 (less disability) and the Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer. | 6 months post op | |
Primary | Tegner Lysholm | Symptom reporting questionnaire made up of two components. The Lysholm score Scores range from 0 (worse disability) to 100 (less disability) and the Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer. | 1 year post op | |
Primary | Tegner Lysholm | Symptom reporting questionnaire made up of two components. The Lysholm score Scores range from 0 (worse disability) to 100 (less disability) and the Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer. | 2 years post op | |
Secondary | KT 1000 | instrumented laxity test | 1 year post op | |
Secondary | KT 1000 | instrumented laxity test | 2 years post op | |
Secondary | return to sport questionnaire | Psychological readiness for return to sport questionnaire, comprises 12 questions with a score of 1 to 10 for each. Where a lower score means a better outcome. | 1 year post op | |
Secondary | return to sport questionnaire | Psychological readiness for return to sport questionnaire, comprises 12 questions with a score of 1 to 10 for each. Where a lower score means a better outcome. | 2 years post op | |
Secondary | hop test | functional test, In this test, the aim is to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. The goal is to have a less than 10% difference in hop distance between the injured limb and uninjured limb. | 1 year post op | |
Secondary | hop test | functional test, In this test, the aim is to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. The goal is to have a less than 10% difference in hop distance between the injured limb and uninjured limb. | 2 years post op | |
Secondary | squat test | functional test, scoring of the movement strategy occurring in individual body regions, where 0 for appropriate strategy and one for inappropriate movements, for each region with best overall score being 0 and worst 10 points | 6 months post op | |
Secondary | squat test | functional test, scoring of the movement strategy occurring in individual body regions, where 0 for appropriate strategy and one for inappropriate movements, for each region with best overall score being 0 and worst 10 points | 1 year post op | |
Secondary | squat test | functional test, scoring of the movement strategy occurring in individual body regions, where 0 for appropriate strategy and one for inappropriate movements, for each region with best overall score being 0 and worst 10 points | 2 years post op |
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