ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of

Status Active, not recruiting

Clinical Trial Summary

ACI-C versus AMIC: A controlled randomized trial comparing Autologous Chondrocyte Implantation ( ACI) and Autologous Matrix Induced Chondrogenesis (AMIC) for repair of cartilage defects in the knee.

Eighty patients (Forty in each group) having symptomatic cartilage defects in their knee are planned to include in this study.

Both techniques will use the ChondroGide membrane from Geistlich to cover the defects. ACI includes an arthroscopy to harvest cartilage for cell cultivation in our lab located in Tromso. 3-4 weeks later using a mini arthrotomy the cells will be implanted under the ChondroGide membrane.

The AMIC group will be listed for a mini arthrotomy, cleaning of the defect, microfracture and cover of the defect using the same ChondroGide membrane.

In both groups stitches and fibrin glue will be used to fix the membrane.

Inclusion criteria:

Age between 18-60, Informed consent signed by patient, Symptomatic cartilage defect. Size more than 2 square cm.

Exclusion criteria Alcohol or drug abuse during the last three years, Inflammatory joint disease, Serious illness

Preoperative examination and follow up: Clinical examination and registration of KOOS (a validated knee score), VAS (visual analog pain scale) and Lysholm knee score. Radiographs of the involved knee including weightbearing standing radiographs of both knees. Kellgren- Lawrence classification will be used for grading of OA.

Patients will be checked after 1, 2, 5 and 10 years following surgery. Symptomatic patients having a new cartilage resurfacing operation or prosthesis will be listed as failures of the initial treatment.

Hypothesis: AMIC will be equal to ACI, and if that is the case this would be a benefit for the patients and the society. AMIC is much cheaper compared to ACI (needing an expensive cell cultivation and two surgeries).

Data will be analyzed using the SPSS statistical package.

Clinical Trial Description

Please see referenced articles (1-3) for details regarding ACI and AMIC ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01458782
Study type	Interventional
Source	University Hospital of North Norway
Contact
Status	Active, not recruiting
Phase	N/A
Start date	October 2011
Completion date	October 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04657926` - A Trial of APPA in the Treatment of Knee Osteoarthritis	Phase 2
Completed	`NCT02536833` - A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects	Phase 2
Completed	`NCT03014037` - Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration	N/A
Recruiting	`NCT05937542` - A Qualitative Investigation of CLEAT Participants
Completed	`NCT03644615` - A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis	N/A
Recruiting	`NCT06061367` - Muscles Strength and Gait Parameteres After TKA
Withdrawn	`NCT04976972` - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation	N/A
Completed	`NCT05496205` - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers	Phase 1
Completed	`NCT03850665` - Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach	N/A
Completed	`NCT02826902` - Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial	N/A
Completed	`NCT04402502` - Dynamic 4DCT to Examine Wrist Carpal Mechanics	N/A
Completed	`NCT02923700` - Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial	Phase 4
Completed	`NCT04564053` - Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants	Phase 1
Completed	`NCT05070871` - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women	N/A
Not yet recruiting	`NCT05036174` - Diphenhydramine Ointment for Knee Osteoarthritis	N/A
Recruiting	`NCT02912429` - Onlay vs. Inlay Patellofemoral Arthroplasty	N/A
Recruiting	`NCT02666443` - Low Dose Dexamethasone in Supraclavicular Blocks	N/A
Active, not recruiting	`NCT02723929` - Effects of tDCS and tUS on Pain Perception in OA of the Knee
Withdrawn	`NCT02921594` - Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties	N/A
Terminated	`NCT02820766` - Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms