Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.

Not Applicable

Recruiting

• Conditions: Anterior Cruciate Ligament Tear
• Interventions: Procedure: autologous bone marrow aspirate concentrate

• Registration Number: NCT06353503
• Lead Sponsor: abdulmajeed hammadi

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.

Study Timeline

• Study First Submitted: 2024-03-26
• Status Verified: 2024-04
• Study Start: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-09-27
• Study Completion: 2024-09-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bone marrow injection	autologous bone marrow aspirate concentrate	intra articular injection of autologous bone marrow aspirate concentrate 4cc in the injured knee under local anesthesia and ultrasound guide

Primary Outcome Measures

Name	Time	Method
Functional recovery by clinical assessments of the ACL and overall knee joint stability.	every 12 weeks till 6 months	lachman test

Secondary Outcome Measures

Name	Time	Method
magnetic resonance imaging of the knee joint	6 months from starting recruitment	to assess the degree of anterior cruciate ligament tear

Trial Locations

Locations (1)

Ministry of Health; 🇮🇶 Baghdad, Iraq