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Safety Profile and Short-term Outcomes of BST-CarGel as an Adjunct to Microfracture for the Treatment of Chondral Lesions of the Hip.

ABSTRACT: Acetabular cartilage lesions are a common abnormality found in patients undergoing hip arthroscopic surgery and may cause pain and functional limitations. Several strategies have been developed to treat chondral defects, with no overwhelming success. Recently, BST-CarGel has gained interest as a scaffolding material that can be injected into the microfracture site to stabilize the clot and facilitate cartilage repair.To perform a retrospective analysis of prospectively collected data to evaluate the safety profile and short-term clinical and radiographic outcomes of patients treated arthroscopically with BST-CarGel for acetabular chondral defects in conjunction with microfracture.Case series; Level of evidence, 4.A retrospective chart review was performed on all patients who underwent hip arthroscopic surgery by the senior surgeon to identify those who had BST-CarGel applied to their hip from November 2014 to July 2016, and basic demographic information for those patients was obtained. Operative reports and patient charts were reviewed to assess intraoperative and postoperative complications as well as to obtain the details of surgery, including lesion size and treatment method of the labrum (repair vs reconstruction). All patients filled out self-reported questionnaires, including the international Hip Outcome Tool (iHOT), Hip Outcome Score-Activities of Daily Living (HOS-ADL), and Hip Outcome Score-Sports Profile (HOS-SP) at the time of consultation and at 1 year postoperatively, and results were used to assess the clinical outcomes of surgery.Thirty-seven patients (37 hips) with a mean age of 36.19 years at the time of the index procedure were evaluated. There were 30 male patients, and 20 procedures were performed on the right hip. The minimum follow-up was 1 year, with a mean follow-up of 12.72 months. There were no major adverse events of deep vein thrombosis, blood vessel or nerve damage, hemarthrosis, arthralgia, or device-related adverse events. Two patients (5.4%) were readmitted because of pain, probably resulting from an inflammatory reaction to BST-CarGel. At 1 year postoperatively, there were statistically significant improvements in the iHOT (40.4 to 59.1; P < .001), HOS-ADL (60.6 to 71.4; P = .02), and HOS-SP (36.9 to 51.6; P = .01) scores. When the patients were subdivided based on the chondral defect size, the iHOT score improved for all chondral defect sizes, and the HOS-SP score improved in patients with medium (2-4 cm2) and very large (>6 cm2) chondral defects. In addition, the iHOT score improved whether the patients had their labrum repaired or reconstructed (P < .001 and P = .02, respectively).The arthroscopic treatment of chondral acetabular defects with BST-CarGel demonstrates a satisfactory safety profile, with statistically significant improvement in patient-reported clinical outcome scores, even for those with very large chondral defect sizes.

SUBMITTER: Rhee C

PROVIDER: S-EPMC6088484 | biostudies-other | 2018 Aug

REPOSITORIES: biostudies-other

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Safety Profile and Short-term Outcomes of BST-CarGel as an Adjunct to Microfracture for the Treatment of Chondral Lesions of the Hip.

Rhee Chanseok C Amar Eyal E Glazebrook Mark M Coday Catherine C Wong Ivan H IH

Orthopaedic journal of sports medicine 20180810 8

<h4>Background</h4>Acetabular cartilage lesions are a common abnormality found in patients undergoing hip arthroscopic surgery and may cause pain and functional limitations. Several strategies have been developed to treat chondral defects, with no overwhelming success. Recently, BST-CarGel has gained interest as a scaffolding material that can be injected into the microfracture site to stabilize the clot and facilitate cartilage repair.<h4>Purpose</h4>To perform a retrospective analysis of prosp ...[more]

PMID: 30116764

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Project description:BackgroundIt is unknown whether unstable chondral lesions observed during arthroscopic partial meniscectomy (APM) require treatment. We examined differences at 1 year with respect to knee pain and other outcomes between patients who had debridement (CL-Deb) and those who had observation (CL-noDeb) of unstable chondral lesions encountered during APM.MethodsPatients who were ≥30 years old and undergoing APM were randomized to receive debridement (CL-Deb group; n = 98) or observation (CL-noDeb; n = 92) of unstable Outerbridge grade-II, III, or IV chondral lesions. Outcomes were evaluated preoperatively and at 8 to 12 days, 6 weeks, 3 months, 6 months, and 1 year postoperatively. Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), visual analog scale (VAS) pain score, Short Form-36 (SF-36) health survey, range of motion, quadriceps circumference, and effusion. The primary outcome was the WOMAC pain score at 1 year. T tests were used to examine group differences in outcomes, and the means and standard deviations are reported.ResultsThere were no significant differences between the groups with respect to any of the 1-year outcome scores. Compared with the CL-Deb group, the CL-noDeb group had improvement in the KOOS quality-of-life (p = 0.04) and SF-36 physical functioning scores (p = 0.01) as well as increased quadriceps circumference at 8 to 12 days (p = 0.02); had improvement in the pain score on the WOMAC (p = 0.02) and KOOS (p = 0.04) at 6 weeks; had improvement in SF-36 physical functioning scores at 3 months (p = 0.01); and had increased quadriceps circumference at 6 months (p = 0.02).ConclusionsOutcomes for the CL-Deb and CL-noDeb groups did not differ at 1 year postoperatively. This suggests that there is no benefit to arthroscopic debridement of unstable chondral lesions encountered during APM, and it is recommended that these lesions be left in situ.Level of evidenceTherapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Project description:PurposeTo evaluate whether the presence of residents in hip arthroscopy (HA) procedures affects short-term surgical outcomes.MethodsThe American College of Surgeons National Surgical Quality Improvement Program Database was used to identify patients who underwent HA from 2006 to 2012. Demographic and 30-day outcome variables were compared between cohorts of patients with and without residents. Multivariate logistic regression was used to identify whether resident involvement was an independent risk factor for adverse outcomes. Propensity score matching was performed to control for all demographic and intraoperative variables.ResultsA total of 869 patients (59.7% female) were included in this study, 626 of which reported data on resident involvement. Patients were mostly White (73.4% of cases without a resident, 51.8% with a resident, P < .05). Those with residents were younger (P = .016), had lower modified 5-item frailty index (mFI-5) scores (P = .028), and had fewer cardiac comorbidities (P = .008). There was no difference in diabetic status, dyspnea symptoms, history of chronic obstructive pulmonary disease, renal comorbidity, neurologic comorbidity, cumulative comorbidities, history of bleeding disorders, inpatient vs. outpatient treatment, preoperative functional status, smoking history, and steroid use for chronic conditions. There was no difference in all complications, operative time, length of stay, reoperation, readmission, wound complication, venous thromboembolism, blood transfusions, or sepsis. Propensity score match for demographic and intraoperative differences found no association between resident involvement and increased complications. Resident involvement was not an independent risk factor for all complications studied.ConclusionResident involvement in HA procedures was not a risk factor for 30-day complications between 2006 and 2012. Resident involvement did not increase the risk of adverse outcomes, readmission, reoperation, or length of stay, nor did it significantly increase operative times.

Project description:BackgroundProvisional 1-stent technique is currently regarded as the default approach for the majority of bifurcation lesions. Nonetheless, 2-stent techniques may be required for complex bifurcations with high compromise risk or fatal consequences of side branch (SB) occlusion. Limitations exist in current approaches, as stents gap, multiple metal layers and stent malapposition caused by imprecise placement with fluoroscopic guide and intrinsic technical defects. This study was designed to investigate the effectiveness of the novel Szabo 2-stent technique for coronary bifurcation lesions.MethodsIn the Szabo 2-stent technique, one stent is precisely implanted at the SB ostium with Szabo technique resulting in a single strut protruding into the main vessel (MV). After MV rewiring and SB guidewire withdrawal, another stent is implanted in MV followed by proximal optimization technique, SB rewiring, and final kissing inflation (FKI).ResultsThe technique tested successfully in silicone tubes (n = 9) with: procedure duration, 31.2 ± 6.8 min; MV and SB rewiring time, 26.8 ± 11.2 s and 33.3 ± 15 s; easy FKI; and 2.3 ± 0.5 balloons/procedure. Bifurcation lesions (n = 22) were treated with angiographic success in MV and SB, respectively: increased minimal lumen diameter (0.63 ± 0.32 mm to 3.20 ± 0.35 mm; 0.49 ± 0.37 mm to 2.67 ± 0.25 mm); low residual stenosis (12.4 ± 2.4%; 12.4 ± 2.3%); and intravascular ultrasound confirmed (n = 19) full coverage; minimal overlap and malapposition; minimal lumen area (2.4 ± 1.2 mm2; 2.1 ± 1.0 mm2); plaque burden (78.1 ± 11.3%; 71.6 ± 15.5%); and minimal stent area (9.1 ± 1.6 mm2; 6.1 ± 1.3 mm2). Periprocedural cardiac troponin increased in 1 asymptomatic patient without electrocardiographic change. There was no target lesion failure (cardiac death, myocardial infarction, target lesion revascularization) at 6-month follow-up.ConclusionsThe Szabo 2-stent technique for bifurcation lesions provided acceptable safety and efficacy at short-term follow-up.

Project description:Background:The results of arthroscopic anterior labral repair have demonstrated high failure rates in patients with significant glenoid bone loss. Several reconstruction procedures using a bone graft have been developed to overcome bone loss. Purpose:The primary objective of this study was to generate a safety profile for arthroscopic anatomic glenoid reconstruction using a distal tibial allograft. The secondary objective was to evaluate the radiological outcomes of patients who underwent this procedure. Study Design:Case series; Level of evidence, 4. Methods:This retrospective review included the medical charts and diagnostic images of 42 consecutive patients who underwent arthroscopic shoulder stabilization by means of capsule-labral reattachment and bony augmentation with a distal tibial allograft. The safety profile was measured by detecting intraoperative or postoperative complications, including neurovascular (nerves and blood vessels) injuries, bleeding, infections, and dislocations. A radiological evaluation was conducted by assessing computed tomography (CT) scans obtained preoperatively and at approximately 6 months postoperatively. Results:A total of 42 patients (29 male, 13 female) with a mean age of 26.73 ± 9.01 years were included. An excellent safety profile was observed, with no intraoperative complications, neurovascular injuries, adverse events, bleeding, or infections. CT bone scans were obtained for 31 patients, and the mean follow-up for CT scanning (to measure resorption and union) was 6.31 ± 1.20 months (range, 6-7.5 months). There were no cases of nonunion or partial union. Thirteen patients (42%) had no resorption, whereas 13 (42%) and 5 (16%) patents had <50% and ≥50% resorption, respectively. Conclusion:Arthroscopic shoulder stabilization with distal tibial allograft reconstruction is a safe operative procedure with a minimal risk to neurovascular structures. Most patients had a healed allograft, but 16% of patients had ≥50% resorption on CT at 6 months. Studies with a longer follow-up are recommended for better assessment of the safety profile.

Dataset Information

Safety Profile and Short-term Outcomes of BST-CarGel as an Adjunct to Microfracture for the Treatment of Chondral Lesions of the Hip.

Publications

Safety Profile and Short-term Outcomes of BST-CarGel as an Adjunct to Microfracture for the Treatment of Chondral Lesions of the Hip.

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