Advertisement

Topics

Autologous Cartilage Implantation vs Arthroscopic Debridement

2015-12-23 06:53:25 | BioPortfolio

Summary

82 patients aged 18-49 years with an isolated focal cartilage defect in the knee will be randomized to either receive autologous cartilage implantation or arthroscopic debridement. Both groups will then undergo a systematic physiotherapy training regime for 6-9 months. The Groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D (European Quality of Life 5 dimensions) as well as clinical examination and radiological findings at 2 years (MRI).

Description

Details Focal cartilage defects in the knee - A randomized controlled trial comparing Autologous Chondrocyte Implantation with arthroscopic debridement Clinical Compare the effect of Autologous Chondrocyte Implantation (ACI) with arthroscopic debridement (AD) in patients with symptomatic full thickness knee cartilage injuries larger than 2cm2.

Focal cartilage injuries in the knee might have devastating effect both in the short term and in the long term. Various surgical treatment options are available; with ACI established as a recognized treatment method for larger lesions. Meta-analysis and systematic reviews have required well-designed, long-term, multicenter studies to evaluate clinical outcomes of ACI with the use of a "no treatment" group as a control group.

H0: There is no difference in KOOS QoL after ACI or AD from baseline to 24 months after surgery.

H1: There is a difference in KOOS QoL after ACI or AD from baseline to 24 months after surgery.

Questionnaires: KOOS, Tegner score, Lysholm score, EQ-5D, VAS (Visual analogue scale).

Physical examination: range of motion and hop test. Radiology: x-ray and MRI of the knee. Primary aim: KOOS quality of life (QoL) subscore. Prospective, single-blinded parallel-group bicenter study with 2 treatment arms.

Approx. 36 months inclusion and 24 months follow up. In total 5 years. 24 months. All will be invited to participate in late controls after 5 and 10 years.

2 Norwegian hospitals: Akershus University Hospital and Oslo University Hospital - Ullevål.

82 patients Inclusion: age 18-50 years old, single symptomatic cartilage defect on femoral condyle or trochlea, defect size larger than 2 cm2, defect ICRS (International Cartilage Repair Society) grade 3-4, ligamentous stable knee, range of motion 5-105°, Lysholm score < 75 and informed consent.

Exclusion: Osteoarthritis, rheumatoid or other systemic arthritis, malalignment > 5° measured on x-rays, BMI > 30, comorbidities that may influence surgery or rehabilitation, pregnancy, inability to complete questionnaires or rehabilitation, serious alcohol or drug abuse, previous cartilage surgery to the chondral defect except OCD (osteochondritis dissecans)surgery.

2 treatment groups with 41 patients in each group. 3 months (± 2 weeks), 6 months (± 4 weeks), 12 months (± 6 weeks) and 24 months (± 8 weeks). All will be invited to participate in late controls after 5 and 10 years.

If any unforeseen complication outside normal clinical practice occurs, the sponsor representative will be contacted as soon as possible with a parallel message to the local coordinators at the involved hospitals. During each follow up, there will be a case report form (CRF) regarding complications and safety.

A 5 mL venous blood sample will be drawn on the day of operation. The blood sample will be centrifuged before serum is pipetted in a sterile tube. The serum will be analyzed at Oslo University Hospital - Rikshospitalet on the cartilage biomarker microRNA-140 (miR-140).

During the open chondrocyte implantation the excess cartilage debrided from the rim of the lesion will be sent for similar microRNA-140 (miR-140) analysis. (applicable for the 41 patients in the ACI arm only) If normal distribution, aims will be analyzed using linear mixed models (LMM), and the primary aim will be performed as a post hoc test for the LMM, similar to performing a two-sample t-test. If no normal distribution, analysis will be performed using Mann-Whitney U-test.

Detecting a difference of 10 in primary aim with 80% power using a standard deviation of 15. A p < 0,05 is statistically significant. This gives 37 patients in each group, adding 10% drop out meaning 41 patients in each group and 82 in total.

No interim analysis will be done. Monitor at Akershus University Hospital. Inclusion of 82 patients. The end of this study is 24 months after the last included patient. Inability to include 82 patients in 3 years. May prolong the inclusion period, or add other including hospitals in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Knee Injury

Intervention

Autologous Chondrocyte Implantation, Arthroscopic Debridement

Status

Not yet recruiting

Source

University Hospital, Akershus

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-12-23T06:53:25-0500

Clinical Trials [3228 Associated Clinical Trials listed on BioPortfolio]

Norwegian Cartilage Project - Microfracture

114 patients between 18 and 50 years with an isolated focal cartilage defect in the knee will be randomized to either receive arthroscopic microfracture or arthroscopic debridement. Both g...

Study on Safety, Tolerability Prelimenary Efficacy of LNA043 in Patients Undergoing Autologous Chondrocyte Implantation

The purpose of this (Proof of Concept) PoC study is to assess safety, tolerability and preliminary efficacy of intra articular (i.a.) LNA043 in regenerating the articular cartilage of the ...

Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial

Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) w...

Autologous Chondrocyte Implantation in the Patellofemoral Joint

The purpose of this study is to measure the outcomes of patients who have articular cartilage lesions in the patellofemoral joint and are treated with the Autologous Chondrocyte Implantati...

Autologous Stromal Vascular Fraction of Cells for Treatment of Knee Articular Cartilage Dystrophy

Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic digestion. SVF will be administered in a single dose intraarticularly 4 weeks after arthroscopic d...

PubMed Articles [7546 Associated PubMed Articles listed on BioPortfolio]

Assessment of Cartilage Growth After Biopsy of Osteochondral Loose Bodies in Adolescent Knees for Use in Autologous Chondrocyte Implantation.

The goal of this study is to determine whether harvested cartilage from an osteochondral loose body maintains the same viability for implantation as cartilage harvested from the traditional locations ...

Graft Hypertrophy After Third-Generation Autologous Chondrocyte Implantation Has No Correlation With Reduced Cartilage Quality: Matched-Pair Analysis Using T2-Weighted Mapping.

Graft hypertrophy is common after matrix-based autologous chondrocyte implantation (ACI) in the knee joint. However, it is not clear whether graft hypertrophy is a complication or an adjustment reacti...

Autologous Chondrocyte Implantation (ACI) for Knee Cartilage Defects: A Review of Indications, Technique, and Outcomes.

Clinical and radiographical ten years long-term outcome of microfracture vs. autologous chondrocyte implantation: a matched-pair analysis.

To compare the clinical and radiographical long-term outcome of microfracture (MFX) and first-generation periosteum-covered autologous chondrocyte implantation (ACI-P).

Mucoid Degeneration of the Anterior Cruciate Ligament: Characterization of Natural History, Femoral Notch Width Index, and Patient Reported Outcome Measures.

The presentation and clinical course of mucoid degeneration of the anterior cruciate ligament (MD-ACL) are poorly documented within the literature. Subsequently, it is under-diagnosed and the optimal ...

Medical and Biotech [MESH] Definitions

An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.

Injuries to the knee or the knee joint.

A region of the lower extremity immediately surrounding and including the KNEE JOINT.

Replacement for a knee joint.

An overuse injury causing lateral knee pain that results from repetitive friction of the iliotibial band over the lateral femoral epicondyle.

More From BioPortfolio on "Autologous Cartilage Implantation vs Arthroscopic Debridement"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Joint Disorders
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...

Radiology
Radiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...


Searches Linking to this Trial