scholarly journals A Randomized, Controlled Trial Comparing Autologous Matrix-Induced Chondrogenesis (AMIC®) to Microfracture: Analysis of 1- and 2-Year Follow-Up Data of 2 Centers

2013 ◽  
Vol 7 (1) ◽  
pp. 133-143 ◽  
Author(s):  
Sven Anders ◽  
Martin Volz ◽  
Hubert Frick ◽  
Jörg Gellissen
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Collagen Type I ◽  
Cartilage Defects ◽  
Type I ◽  
Randomized Controlled ◽  
First Results ◽  
Post Operation

Microfracture (MFx) is currently the recommended option for the treatment of small cartilage defects but is not regarded as suitable for the treatment of defects larger than 2.5 cm2. To extent its applicability to medium-sized defects MFx has been combined with a collagen type I/III matrix (Chondro-Gide®). This technique is called Autologous Matrix-Induced Chondrogenesis (AMIC®) and meanwhile a clinically established treatment option for localized full-thickness small- to medium-sized cartilage defects. Despite its more spreading clinical use, clinical data published so far are limited to mainly case report series.In this study, we report the first results of a randomized, controlled trial assessing the efficacy and safety of AMIC®versus MFx. Patients enrolled in 2 centers were included in this analysis. 38 patients (aged 21-50 years, mean defect size 3.4 cm2) were randomized and treated either with MFx, with sutured AMIC®or glued AMIC®. Clinical outcomes (modified Cincinnati and ICRS score) could be assessed in 30 patients at 1-year and 27 patients at 2-years post-operation. Improvements in both scores were seen at 1-and 2-years post-operation, irrespective of the technique used. MRI assessment revealed a satisfactory and homogenous defect filling in the majority of patients. No treatment-related adverse events were reported.This interim analysis confirms the mid-term results for AMIC®reported in literature. It demonstrates clearly that clinical outcomes at 1-year post-operation are maintained at 2-years. Therefore we consider enhancing MFx with Chondro-Gide®is a valid and safe cartilage repair option for small- to medium-sized cartilage defects of the knee.

scholarly journals Collagen-Covered Autologous Chondrocyte Implantation Versus Autologous Matrix-Induced Chondrogenesis: A Randomized Trial Comparing 2 Methods for Repair of Cartilage Defects of the Knee

2019 ◽  
Vol 7 (9) ◽  
pp. 232596711986821 ◽  
Author(s):  
Vegard Fossum ◽  
Ann Kristin Hansen ◽  
Tom Wilsgaard ◽  
Gunnar Knutsen
Keyword(s):  
Randomized Controlled Trial ◽  
Autologous Chondrocyte Implantation ◽  
Controlled Trial ◽  
Long Term Results ◽  
Cartilage Defects ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Chondrocyte Implantation ◽  
Autologous Chondrocyte

Background:Autologous matrix-induced chondrogenesis (AMIC) is a single-stage alternative to autologous chondrocyte implantation for treatment of localized cartilage defects of the knee. To our knowledge, no randomized controlled trial exists comparing the 2 methods.Purpose:To evaluate any difference in the outcome of AMIC as compared with collagen-covered autologous chondrocyte implantation (ACI-C).Study Design:Randomized controlled trial; Level of evidence, 2.Methods:A prospective randomized controlled clinical trial was designed to assess any differences in the outcomes between ACI-C and AMIC for the treatment of ≥1 chondral or osteochondral defects of the distal femur and/or patella. The inclusion period was set to 3 years, and the aim was to include 80 patients (40 in each group). Patient inclusion was broad, with few exclusion criteria. The primary outcome was change in Knee injury and Osteoarthritis Outcome Score (KOOS) at 2 years as compared with baseline. The secondary outcomes were the number of failures in each group at 2 years and the change in KOOS subscale, Lysholm, and pain visual analog scale (VAS) scores at 2 years as compared with baseline. A 2-sample t test with a significance level of P < .05 was used to compare the change in score from baseline between groups.Results:A total of 41 patients over 3 years were included in the study: 21 in the ACI-C group and 20 in the AMIC group. All the patients had prior surgery to the index knee. At 2-year follow-up, the clinical scores for both groups improved significantly from baseline. No significant differences between groups were seen in the change from baseline for KOOS (AMIC, 18.1; ACI-C, 10.3), any of the KOOS subscales, the Lysholm score (AMIC, 19.7; ACI-C, 17.0), or the VAS pain score (AMIC, 30.6; ACI-C, 19.6). Two patients in the AMIC group had progressed to a total knee replacement by the 2-year follow-up as compared with none in the ACI-C group.Conclusion:At 2-year follow-up, no significant differences were found regarding outcomes between ACI-C and AMIC. Mid- and long-term results will be important.Registration:NCT01458782 ( ClinicalTrials.gov identifier).

Effect of spinal cord stimulation for chronic complex regional pain syndrome Type I: five-year final follow-up of patients in a randomized controlled trial

2008 ◽  
Vol 108 (2) ◽  
pp. 292-298 ◽  
Author(s):  
Marius A. Kemler ◽  
Henrica C. W. de Vet ◽  
Gerard A. M. Barendse ◽  
Frans A. J. M. van den Wildenberg ◽  
Maarten van Kleef
Keyword(s):  
Spinal Cord ◽  
Randomized Controlled Trial ◽  
Pain Relief ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Type I ◽  
Syndrome Type ◽  
Randomized Controlled ◽  
To Receive

Object Chronic complex regional pain syndrome–Type I (CRPS-I) is a painful, disabling disorder for which no treatment with proven effect is available. In the present randomized controlled trial, the authors assessed the effectiveness of spinal cord stimulation (SCS) in reducing pain due to CRPS-I at the 5-year follow-up. Methods The authors performed a randomized trial in a 2:1 ratio in which 36 patients with CRPS-I were allocated to receive SCS and physical therapy (PT) and 18 patients to receive PT alone. Twenty-four patients who received SCS+PT also underwent placement of a permanent spinal cord stimulator after successful test stimulation; the remaining 12 patients did not receive a permanent stimulator. The authors assessed pain intensity, global perceived effect, treatment satisfaction, and health-related quality of life. Patients were examined before randomization, before implantation, and every year until 5 years thereafter. Ten patients were excluded from the final analysis. Results At 5 years posttreatment, SCS+PT produced results similar to those following PT for pain relief and all other measured variables. In a subgroup analysis, the results with regard to global perceived effect (p = 0.02) and pain relief (p = 0.06) in 20 patients with an implant exceeded those in 13 patients who received PT. Conclusions Despite the diminishing effectiveness of SCS over time, 95% of patients with an implant would repeat the treatment for the same result.

scholarly journals Intra-articular Injection of Type I Atelocollagen to Alleviate Knee Pain: A Double-Blind, Randomized Controlled Trial

Cartilage ◽  
2019 ◽  
pp. 194760351986530 ◽  
Author(s):  
Hwa Sung Lee ◽  
Kwang Jun Oh ◽  
Young Wan Moon ◽  
Yong In ◽  
Han Jun Lee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Knee Pain ◽  
Short Form ◽  
Controlled Trial ◽  
Cartilage Defects ◽  
Type I ◽  
Double Blind ◽  
Randomized Controlled ◽  
Sf 36

Objective Collagen disruption is one of the underlying causes of knee pain in patients with osteoarthritis and/or diverse cartilage defects. Atelocollagen is a type of collagen that lacks telopeptides and thus has reduced antigenicity. The intra-articular injection of type I atelocollagen supplements collagen levels in the disrupted articular cartilage. This randomized controlled trial evaluated the effects of the intra-articular injection of atelocollagen for the management of knee pain. Design Two hundred patients with osteoarthritis, chondromalacia, or other cartilage defects were randomly assigned to receive a 3-mL intra-articular injection of atelocollagen (BioCollagen group) or saline (Placebo group). Clinical improvement was evaluated over a 24-week period using the 100-mm visual analogue scale (VAS), the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and the 36-item Short-Form Health Survey (SF-36). Results VAS scores were significantly better in the BioCollagen group as compared with the Placebo group at 24 weeks. More patients in the BioCollagen group reported exceeding 20% and 40% VAS improvements. The WOMAC and SF-36 scores were also significantly improved from baseline after the intra-articular injection of atelocollagen; although, the differences between the BioCollagen and Placebo groups were not significant. There were no unexpected or severe adverse events reported for either group. Conclusions The results show that an intra-articular injection of atelocollagen effectively alleviates knee pain, as intended. Therefore, the intra-articular injection of atelocollagen can be considered an alternative solution to controlling knee pain due to osteoarthritis and diverse cartilage defects.

Is It Necessary to Repair Stable Ramp Lesions of the Medial Meniscus During Anterior Cruciate Ligament Reconstruction? A Prospective Randomized Controlled Trial

2017 ◽  
Vol 45 (5) ◽  
pp. 1004-1011 ◽  
Author(s):  
Xin Liu ◽  
Hui Zhang ◽  
Hua Feng ◽  
Lei Hong ◽  
Xue-song Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Outcomes ◽  
Acl Reconstruction ◽  
Medial Meniscus ◽  
Controlled Trial ◽  
Control Group ◽  
Study Group ◽  
Randomized Controlled ◽  
Kt 1000

Background: A special type of meniscal lesion involving the peripheral attachment of the posterior horn of the medial meniscus (PHMM), termed a “ramp lesion,” is commonly associated with an anterior cruciate ligament (ACL) injury. However, its treatment is still controversial. Recently, stable ramp lesions treated with abrasion and trephination alone have been shown to have good clinical outcomes after ACL reconstruction. Hypothesis: Stable ramp lesions treated with abrasion and trephination alone during ACL reconstruction will result in similar clinical outcomes compared with those treated with surgical repair. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A prospective randomized controlled study was performed in 91 consecutive patients who had complete ACL injuries and concomitant stable ramp lesions of the medial meniscus. All patients were randomly allocated to 1 of 2 groups based on whether the stable ramp lesions were surgically repaired (study group; n = 50) or only abraded and trephined (control group; n = 41) during ACL reconstruction. All surgical procedures were performed by a single surgeon who was blinded to the functional assessment findings of the patients. The Lysholm score, subjective International Knee Documentation Committee (IKDC) score, and stability assessments (pivot-shift test, Lachman test, KT-1000 arthrometer side-to-side difference, and KT-1000 arthrometer differences of <3, 3-5, and >5 mm) were evaluated preoperatively and at the last follow-up. Moreover, magnetic resonance imaging (MRI) was used to evaluate the healing status of the ramp lesions. Results: All consecutive patients who were screened for eligibility from August 2008 to April 2012 were enrolled and observed clinically. There were 40 patients in the study group and 33 patients in the control group who were observed for at least 2 years. At the final follow-up, there were no significant differences between the study group and the control group in terms of the mean Lysholm score (88.7 ± 4.8 vs 90.4 ± 5.8, respectively; P = .528), mean subjective IKDC score (83.6 ± 3.7 vs 82.2 ± 4.5, respectively; P = .594), pivot-shift test results ( P = .658), Lachman test results ( P = .525), KT-1000 arthrometer side-to-side difference (1.6 ± 1.2 vs 1.5 ± 1.1, respectively; P = .853), or KT-1000 arthrometer grading ( P = .738). Overall, for both groups (n = 73), 67 patients showed completely healed (38 study, 29 control), 3 showed partially healed (1 study, 2 control), and 3 showed nonhealed (1 study, 2 control) signals on follow-up MRI when evaluating the healing status of the ramp lesions. There was no significant difference regarding the healing status of the ramp lesions between the 2 groups ( P = .543). Conclusion: This prospective randomized controlled trial showed that, in terms of subjective scores, knee stability, and meniscal healing status, concomitant stable ramp lesions of the medial meniscus treated with abrasion and trephination alone during ACL reconstruction resulted in similar clinical outcomes compared with those treated with surgical repair.

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