Anterior Cruciate Ligament Tear
Conditions
Brief summary
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
local knee joint injection of autologous bone marrow
Sponsors
abdulmajeed hammadi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single armed study open label
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional recovery by clinical assessments of the ACL and overall knee joint stability. | every 12 weeks till 6 months | lachman test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| magnetic resonance imaging of the knee joint | 6 months from starting recruitment | to assess the degree of anterior cruciate ligament tear |
Countries
Iraq
Contacts
STUDY_DIRECTORabdulmajeed a hammadi, MD
clinical stem cell studies
Outcome results
None listed