A multicenter randomized controlled trial: matrix-augmented bone marrow stimulation with a polyglycolic acid membrane with hyaluronan vs. microfracture alone in local femoral cartilage defects of the femoral condyles

Aims and Objectives: Microfracture is the gold standard for the treatment of small localized chondral defects of the knee joint. There is evidence from animal studies that the augmentation of bone marrow stimulation by a matrix improves the quality of the repair tissue (matrix-augmented bone marrow stimulation = m-BMS). Aim of this randomized controlled trial was to examine the outcome of a matrix made of polyglycolic acid and hyaluronan in comparison to a conventional microfracture technique. Materials and Methods: In a randomized controlled trail (RCT) patients between 18-60 years with an articular femoral cartilage defect of 1-4 cm2 in the weight bearing area of the femoral condyles with indication for MF were enrolled and randomized to MF or m-BMS using a polyglycolic acid membrane with hyaluronan. Defect filling in MRI assessment at 12 weeks postoperatively was defined as primary outcome measure. MRI scans and follow up examinations including patient reported clinical outcome scores (VAS pain, KOOS, IKDC and SF-36) were performed at 12, 54 and 108 weeks after surgery. Results: There was no statistically significant difference between both groups in terms of defect filling assessed by MRI at 12, 54 and 108 weeks postoperatively. At 12 weeks there was a tendency towards higher degree of defect filling in the MF group when compared to the m-BMS group, whereas no difference was found after 54 and 108 weeks. The m-BMS group revealed superiority in terms of improvement over time in the KOOS subscales pain, knee-related symptoms, activity of daily living, sports and recreation and quality of life at 54 weeks and 108 weeks after treatment. Conclusion: This is the first RCT comparing m-BMS using a polyglycolic acid membrane with hyaluronan to any different treatment strategy in localized cartilage defects of any human joint. The use of the Chondrotissue® membrane in m-BMS of cartilage defects has proven to be a safe procedure with side effects comparable to those of MF. There seems to be an accelerated formation of cartilage repair tissue after MF when compared to m-BMS at 12 weeks postoperatively, whereas at one and two years after treatment there was no difference concerning the quantity of repair tissue. The improvement in clinical outcome scores over time after m-BMS might be due to the formation of cartilage repair tissue of higher quality. Long term follow up studies including histological assessment are desirable for further investigation.

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Matrix-Augmented Bone Marrow Stimulation With a Polyglycolic Acid Membrane With Hyaluronan vs Microfracture in Local Cartilage Defects of the Femoral Condyles: A Multicenter Randomized Controlled Trial

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120922938 ◽

2020 ◽

Vol 8 (5) ◽

pp. 232596712092293

Author(s):

Johannes Glasbrenner ◽

Wolf Petersen ◽

Michael J. Raschke ◽

Matthias Steiger ◽

René Verdonk ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Polyglycolic Acid ◽

Tissue Formation ◽

Bone Marrow Stimulation ◽

Randomized Controlled ◽

Significant Difference ◽

Patient Reported

Background: Microfracture (MF) is an established operative treatment for small, localized chondral defects of the knee joint. There is evidence from animal studies that matrix augmentation of bone marrow stimulation (m-BMS) can improve the quality of the repair tissue formation. Purpose: To evaluate the therapeutic outcome of a matrix made of polyglycolic acid and hyaluronan as compared with a conventional MF technique. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients between the ages of 18 and 68 years who had an articular femoral cartilage defect of 0.5 to 3 cm2 in the weightbearing area of the femoral condyles with indication for MF were included in this study. Patients were randomized and treated with either MF or m-BMS with Chondrotissue. Defect filling, as assessed on magnetic resonance imaging (MRI), at postoperative 12 weeks was defined as the primary outcome measure, with follow-up MRI at weeks 54 and 108. Follow-up data were also collected at 12, 54, and 108 weeks after surgery and included patient-reported clinical scores: visual analog scale for pain, Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee score, and 36-Item Short Form Health Survey. Results: MRI scans confirmed cartilage repair tissue formation in both groups 12 weeks after treatment. There was no significant difference between the m-BMS and MF groups in the percentage of defect filling at 12, 54, and 108 weeks postoperatively. No significant difference was found in terms of patient-reported clinical scores. Both groups showed significant improvement in 4 KOOS subscales—Pain, Activities of Daily Living, Sport and Recreation, and Quality of Life—at 54 and 108 weeks after treatment. Conclusion: This is the first randomized controlled trial comparing m-BMS with a polyglycolic acid matrix with hyaluronan with MF. The use of the Chondrotissue implant in m-BMS has been proven to be a safe procedure. No difference was found between m-BMS and MF in terms of patient-reported outcome scores and MRI assessment until postoperative 2 years. Long-term follow-up studies including histological assessment are desirable for further investigation. Registration: EUCTR2011-003594-28-DE (EU Clinical Trials Register).

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Impact of Early Weightbearing After Ankle Arthroscopy and Bone Marrow Stimulation for Osteochondral Lesions of the Talus

Orthopaedic Journal of Sports Medicine ◽

10.1177/23259671211029883 ◽

2021 ◽

Vol 9 (9) ◽

pp. 232596712110298

Author(s):

Richard M. Danilkowicz ◽

Nathan L. Grimm ◽

Gloria X. Zhang ◽

Thomas A. Lefebvre ◽

Brian Lau ◽

...

Keyword(s):

Bone Marrow ◽

Statistical Significance ◽

Osteochondral Lesion ◽

Ankle Arthroscopy ◽

Categorical Variables ◽

Cartilage Defects ◽

Osteochondral Lesions ◽

Bone Marrow Stimulation ◽

Gold Standard Method ◽

Marrow Stimulation

Background: Osteochondral lesion of the talus (OLT) may be caused by osteochondritis dissecans, osteochondral fractures, avascular necrosis, or focal arthritic changes. For certain focal cartilage defects, bone marrow stimulation (BMS) has been a widely used technique to restore a fibrocartilage substitute overlying the defect. There are various postoperative weightbearing protocols for this procedure, with no single gold standard method. Purpose: To retrospectively review the outcomes of patients undergoing ankle arthroscopy with concomitant BMS to determine outcomes based on postoperative weightbearing status. Study Design: Cohort study; Level of evidence, 3. Methods: We retrospectively reviewed the records of patients who underwent ankle arthroscopy with BMS for OLTs between 2015 and 2018. Patients were placed into 2 cohorts based on postoperative immobilization status: the nonweightbearing (NWB) group and the weightbearing-as-tolerated (WBAT) group. Patient characteristics obtained included age, sex, comorbidities, and etiology of talar pathology. Outcomes included the pain visual analog scale (VAS), range of motion (ROM), complications, time to first weightbearing, and the method and length of immobilization. Patients who were lost to follow-up before 30 days were excluded. The chi-square test was used to compare categorical variables between cohorts, and the t test was used for continuous variables. Results: A total of 69 patients met the inclusion criteria for this study, 18 in the WBAT group and 51 in the NWB group. The mean lesion size was 9.48 × 9.21 mm (range, 3-15 mm × 2-20 mm) for the NWB group and 9.36 × 9.72 mm (range, 5-14 mm × 6-20 mm) for the WBAT group ( P > .05). The VAS scores improved from 4.40 to 0.67 for the WBAT group and from 6.33 to 2.55 for the NWB group, with the difference in final values reaching statistical significance ( P = .0002). Postoperative ROM was not significantly different between the groups. There were 4 repeat operations within the NWB cohort. Conclusion: The surgical management of OLTs can be challenging, and the postoperative weightbearing protocol can be an extra obstacle for the patient to navigate. We found no difference in pain, ROM, or complications when allowing immediate, full WBAT.

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Systematic review of bone marrow stimulation for osteochondral lesion of talus - evaluation for level and quality of clinical studies

World Journal of Orthopedics ◽

10.5312/wjo.v8.i12.956 ◽

2017 ◽

Vol 8 (12) ◽

pp. 956-963 ◽

Cited By ~ 7

Author(s):

Youichi Yasui ◽

Laura Ramponi ◽

Dexter Seow ◽

Eoghan T Hurley ◽

Wataru Miyamoto ◽

...

Keyword(s):

Systematic Review ◽

Bone Marrow ◽

Clinical Studies ◽

Osteochondral Lesion ◽

Bone Marrow Stimulation ◽

Marrow Stimulation ◽

Osteochondral Lesion Of Talus

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Effect of subchondral bone sclerosis in repair tissue after bone marrow stimulation for osteochondral talar lesions

Foot & Ankle Orthopaedics ◽

10.1177/2473011418s00525 ◽

2018 ◽

Vol 3 (3) ◽

pp. 2473011418S0052

Author(s):

Ichiro Yoshimura ◽

Tomonobu Hagio ◽

Kazuki Kanazawa ◽

Masahiro Suzuki ◽

Takuaki Yamamoto

Keyword(s):

Bone Marrow ◽

Subchondral Bone ◽

Cartilage Tissue ◽

Osteochondral Lesions ◽

Lesion Length ◽

Bone Marrow Stimulation ◽

Repair Tissue ◽

Marrow Stimulation ◽

Bone Sclerosis ◽

The Relationship

Category: Arthroscopy Introduction/Purpose: The arthroscopic bone marrow stimulation (ABMS) technique is the first-line procedure for the treatment of osteochondral lesions of the talus (OLT). Recently, T2 mapping was used to evaluate repair cartilage tissue, but the prognostic factors for T2 values after ABMS have never been clarified. Some patients have OLT with sclerotic changes in the subchondral bone, and several articles have suggested that the subchondral bone condition affects the condition of the articular cartilage. Furthermore, subchondral bone sclerosis (SBC) was found to be associated with an inferior outcome after ABMS.The purpose of this study was to investigate the relationship between subchondral bone sclerotic changes and repair tissue T2 values on MRI after ABMS. Methods: Twenty ankles in 20 patients treated with ABMS for OLT were evaluated. The patients included 7 males and 13 females (age, 30.52±21.44 years, lesion length 10.4±3.0mm, lesion area 55.7±26.5mm2). Repair tissue was assessed using a 3T MRI unit, and T2 maps were calculated at the one-year post-ABMS follow up. The patients were divided into two groups; with SBC and without SBC on pre-ABMS CT images. We investigated the relationship between T2 values and SBC. Clinical results were measured using the Japanese Society for Surgery of the Foot (JSSF) Ankle-Hindfoot Scale. Results: No significant mean differences were found in T2 values or JSSF scores between the with SBC and without SBC groups post-ABMS (T2 values; 48.2±3.3ms vs. 50.1±2.9ms, P=0.7 / JSSF scale score; 89.4±5.8 points vs. 93.3±8.2 points, P=0.25). Lesion length was correlated with the T2 values of repair tissue (Length; r=0.3 P=0.01). Age and BMI were not significantly correlated with T2 values of the repair tissue. Conclusion: The presence of SBC prior to ABMS did not affect the T2 values of repair tissue after ABMS. However, we believe that lesion size affected the condition of the repair tissue.

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Microfracture Versus Drilling of Articular Cartilage Defects: A Systematic Review of the Basic Science Evidence

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120945313 ◽

2020 ◽

Vol 8 (8) ◽

pp. 232596712094531 ◽

Cited By ~ 1

Author(s):

Matthew J. Kraeutler ◽

Gianna M. Aliberti ◽

Anthony J. Scillia ◽

Eric C. McCarty ◽

Mary K. Mulcahey

Keyword(s):

Systematic Review ◽

Articular Cartilage ◽

Cartilage Repair ◽

Basic Science ◽

Science Studies ◽

Cartilage Regeneration ◽

Cartilage Defects ◽

Repair Tissue ◽

Marrow Stimulation

Background: Microfracture (MFx) is one of the most common techniques used for the treatment of articular cartilage defects, although recently there has been a trend toward the use of drilling rather than MFx for the treatment of these defects. Purpose: To perform a systematic review of basic science studies to determine the effect of microfracture versus drilling for articular cartilage repair. Study Design: Systematic review. Methods: A systematic review was performed by searching PubMed, the Cochrane Library, and EMBASE to identify basic science studies comparing outcomes of MFx versus drilling. The search phrase used was microfracture AND (drilling OR microdrilling). Inclusion criteria were basic science studies that directly compared the effect of MFx versus drilling on subchondral bone, bone marrow stimulation, and cartilage regeneration. Results: A total of 7 studies met the inclusion criteria and were included in this systematic review. Of these, 4 studies were performed in rabbits, 1 study in sheep, and 2 studies in humans. All of the included studies investigated cartilage repair in the knee. In the animal studies, microfracture produced fractured and compacted bone and led to increased osteocyte necrosis compared with drilling. Deep drilling (6 mm) was superior to both shallow drilling (2 mm) and MFx in terms of increased subchondral hematoma with greater access to marrow stroma, improved cartilage repair, and increased mineralized bone. However, the overall quality of cartilage repair tissue was poor regardless of marrow stimulation technique. In 2 studies that investigated repair tissue after MFx and/or drilling in human patients with osteoarthritis and cartilage defects, the investigators found that cartilage repair tissue did not achieve the quality of normal hyaline articular cartilage. Conclusion: In the limited basic science studies that are available, deep drilling of cartilage defects in the knee resulted in improved biological features compared with MFx, including less damage to the subchondral bone and greater access to marrow stroma. Regardless of marrow stimulation technique, the overall quality of cartilage regeneration was poor and did not achieve the characteristics of native hyaline cartilage. Overall, there is a general lack of basic science literature comparing microfracture versus drilling for focal chondral defects.

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Results of Arthroscopic Talar Osteochondral Lesions with Bone Marrow Stimulation and BST-CarGel

Foot & Ankle Orthopaedics ◽

10.1177/2473011419s00163 ◽

2019 ◽

Vol 4 (4) ◽

pp. 2473011419S0016

Author(s):

Jagwinder Dhaliwal ◽

Andrew Wines

Keyword(s):

Quality Of Life ◽

Bone Marrow ◽

Functional Outcome ◽

Osteochondral Lesions ◽

Foot And Ankle ◽

Bone Marrow Stimulation ◽

Marrow Stimulation ◽

The Mean

Category: Ankle, Trauma Introduction/Purpose: Osteochondral lesions (OCL) are described as any defect involving both the articular surface and the subchondral bone of the talus. They are commonly associated with acute ankle injuries occurring often in active population. Bone marrow stimulation with microfracture is a standard reparative treatment for OCD however decline in related functional outcome has been reported. BST-CarGel contains chitosan which binds to negatively charged cartilage surface acting as biocompatible scaffold. This allows repair tissue with significant filling volume and proper integration into the surroundings. There has been reported better quantitative and qualitative cartilage repair tissue at 12 months with BST-CarGel. We first report on clinical results of bone marrow stimulation and BST-Cargel for recalcitrant talar OCL in patients previously treated with microfracture alone in a prospective study. Methods: This prospective single surgeon series was limited to patients with symptomatic OCL who previously had arthroscopic debridement and microfracture for same lesion. The pre-operative evaluation of all patients involved clinical assessment, weight bearing plain radiographs and magnetic resonance imaging of ankle joint. Inclusion criteria were age 18-55 years, single focal OCL of talus less than 3 cm2 and previous microfracture. Exclusion criteria was evidence of ankle osteoarthritis and allergy to chitosan or known hypersensitivity to crustaceans such as shrimp, lobster, and crab. Functional outcome assessment was measured using Foot and Ankle outcome score (FAOS) and EQ5D (Health related quality of life) pre and post-operatively. We used paired Student’s t-test for statistical analysis. Values for p < 0.05 were regarded as significant. The surgical technique used have been previously described in literature for OCL of the talus treated with bone marrow stimulation and Cargel. Results: There were fourteen patients who were treated with arthroscopic BST-Cargel with BMS and followed up prospectively. There was no loss to follow-up. The mean follow-up post-operatively was 28 months. There were eight males and six females in the study group. Patient mean age at the time of operation was 42 years (21–60 years). The mean size of talar OCL treated was 2.8 cm2 . Mean FAOS score for symptoms pre-operatively was 41.7 and post-operative was 52.8 (P<0.01). Mean FAOS pain subscale pre-operatively was 45.7 and post-operatively 55.6 (P<0.01). FAOS function and daily living score pre-operatively was 41.4 and post-operatively was 55.8 (P<0.01). Mean FAOS quality of life score was 39.2 pre-operatively and post-operative score 57.2 (P<0.01). EQ5D pre-operatively was 15 and post-operatively was 8 (P<0.01). Conclusion: We noted statistically significant improvement in each subscale of The Foot and Ankle Outcome questionnaire scores post-operatively. There was also significant improvement in generic health status instrument EQ-5D. We also noted talar OCL improvement on MRI scan taken pre and post BST-CarGel treatment. Recalcitrant OCL of talus present considerable challenge with persistent pain, functional limitations and secondary osteoarthritis. BST-Cargel treatment in our clinical study improved functional outcome scores similar to previously reported hip and knee studies. It requires standard arthroscopic technique and no complications were observed in our study.

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Preoperative bone marrow stimulation does not improve functional outcomes in arthroscopic cuff repair: a prospective randomized controlled trial

The Bone & Joint Journal ◽

10.1302/0301-620x.103b1.bjj-2020-0011.r2 ◽

2021 ◽

Vol 103-B (1) ◽

pp. 123-130

Author(s):

Peter Lapner ◽

J. W. Pollock ◽

Odette Laneuville ◽

Hans K. Uhthoff ◽

Tinghua Zhang ◽

...

Keyword(s):

Rotator Cuff ◽

Rotator Cuff Repair ◽

Controlled Trial ◽

Arthroscopic Rotator Cuff Repair ◽

Bone Marrow Stimulation ◽

Marrow Stimulation ◽

Randomized Controlled ◽

Prospective Randomized Controlled Trial ◽

Arthroscopic Rotator Cuff ◽

Cuff Repair

Aims Despite recent advances in arthroscopic rotator cuff repair, re-tear rates remain high. New methods to improve healing rates following rotator cuff repair must be sought. Our primary objective was to determine if adjunctive bone marrow stimulation with channelling five to seven days prior to arthroscopic cuff repair would lead to higher Western Ontario Rotator Cuff (WORC) scores at 24 months postoperatively compared with no channelling. Methods A prospective, randomized controlled trial was conducted in patients undergoing arthroscopic rotator cuff repair. Patients were randomized to receive either a percutaneous bone channelling of the rotator cuff footprint or a sham procedure under ultrasound guidance five to seven days prior to index surgery. Outcome measures included the WORC, American Shoulder and Elbow Surgeons (ASES), and Constant scores, strength, ultrasound-determined healing rates, and adverse events. Results Overall, 94 patients were randomized to either bone channelling or a sham procedure. Statistically significant improvements in all clinical outcome scores occurred in both groups from preoperative to all timepoints (p < 0.001). Intention-to-treat analysis revealed no statistical differences in WORC scores between the two interventions at 24 months postoperatively (p = 0.690). No differences were observed in secondary outcomes at any timepoint and healing rates did not differ between groups (p = 0.186). Conclusion Preoperative bone channelling one week prior to arthroscopic rotator cuff repair was not associated with significant improvements in WORC, ASES, Constant scores, strength, or ultrasound-determined healing rates. Cite this article: Bone Joint J 2021;103-B(1):123–130.

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