Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: autologous bone marrow aspirate concentrate.
- Who it may be relevant to
- Registry conditions: Anterior Cruciate Ligament Tear. Basic parameters: 20 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Using Autologous Bone Marrow Aspirate Concentrate to Treat Complete Anterior Cruciate Ligament Tear.
Overview
A single armed multicenter study enrolling 20 patients using autologous bone marrow aspirate concentrate (which is done under local or general anesthesia to aspirate around 1-2 cc/kg body weight then concentration which is done by using centrifugation and special disposable kit) local injection of 4 cc per joint under ultrasonic guidance ,completely sterile field with local anesthesia.
Detailed description
The anterior cruciate ligament (ACL) is key to the functional stability of the knee joint and is highly susceptible to injury, especially in athletes engaged in high-impact sports. Conventional treatment for partial tears may involve conservative management; however, complete tears often necessitate surgical reconstruction. In seeking alternative treatments, this study investigates the potential of bone marrow aspirate concentrate BMAC-a regenerative medicine approach-to promote healing and restore functionality to completely torn ACLs. The regenerative properties of BMAC, attributed to the presence of stem cells and growth factors, may facilitate ligament repair and regeneration. the team aim treating 1st and 2nd degree anterior cruciate ligament tear without retraction.
Interventions
- Procedure autologous bone marrow aspirate concentrate
local knee joint injection of autologous bone marrow
Primary outcome measures
- Functional recovery by clinical assessments of the ACL and overall knee joint stability. [Time frame: every 12 weeks till 6 months]
Secondary outcome measures (1)
- magnetic resonance imaging of the knee joint [Time frame: 6 months from starting recruitment]
Eligibility criteria
Inclusion criteria
1- Confirmed diagnosis of complete or partial ACL tear via clinical examination and imaging studies.
2\. Aged between 20 and 55 years, to encompass the typical age range of patients with sports-related ACL injuries.
Exclusion criteria
1- Patients with a history of bleeding disorders, as this could complicate the aspiration and injection procedures.
2\. Individuals with a history of malignancy, due to the potential risks associated with growth factors present in BMAC.
3\. Critically ill patients or those with comorbidities
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Iraq · 1 center
- Ministry of Health — Baghdad
Identifiers
NCT: NCT06353503 · KAZ