Hydrogel-based and spheroid-based autologous chondrocyte implantation of the knee show similar 2-year functional outcomes: An analysis based on the German Cartilage Registry (KnorpelRegister DGOU).

PURPOSE: To compare short-term patient-reported outcomes (PRO) of two contemporary matrix-associated autologous chondrocyte implantation (M-ACI) products for the treatment of large articular cartilage defects of the knee. METHODS: A retrospective, registry-based, matched-pair analysis was performed, comparing PRO of patients undergoing isolated M-ACI with either Spherox™, a spheroid-based ACI (Sb-ACI), or NOVOCART™ Inject, a hydrogel-based ACI product (Hb-ACI), for a focal full-thickness cartilage defect of the knee ≥4 cm2. Matching parameters included age, sex, body mass index, defect size, defect localization, symptom duration and previous surgeries. The Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee (IKDC) score were obtained up to the 24-month follow-up. The total KOOS response rate and percentage of patients attaining a substantial clinical benefit (SCB) in KOOS subscores were calculated. RESULTS: A total of 45 patients per group were matched. The response rate after 24 months was not significantly different between the groups (Sb-ACI 64.4% vs. Hb-ACI 82.2%, p = 0.057). The number of patients with a SCB at 24 months was not significantly different in any KOOS subscore, despite significantly higher improvement of the total KOOS (14.8 ± 16.2 vs. 21.5 ± 15.4, p = 0.047) and KOOS pain in the Hb-ACI group (12.2 ± 18.6 vs. 20.6 ± 19.1, p = 0.037). The IKDC score in the Hb-ACI group was significantly higher at the 12- and 24-month follow-up (60.7 ± 20.2 vs. 70.9 ± 18.0, p = 0.013). CONCLUSION: The response rate and number of patients achieving an SCB were not significantly different between patients treated with Sb-ACI or Hb-ACI. Both procedures can achieve favourable 2-year PRO. Hb-ACI was associated with better PRO between 1 and 2 years postoperatively; however, the clinical relevance of this benefit is yet to be proven. LEVEL OF EVIDENCE: III, Retrospective comparative study.

Increased risk of reoperation and failure to attain clinically relevant improvement following autologous chondrocyte implantation of the knee in female patients and individuals with previous surgeries: a time-to-event analysis based on the German cartilage registry (KnorpelRegister DGOU).

PURPOSE: This study aimed to analyze the risk of reoperation following autologous chondrocyte implantation (ACI) of the knee utilizing third-generation ACI products in a time-to-event analysis and report on the associated patient-reported outcome measures (PROM) in case of reoperation. METHODS: Patients undergoing ACI were included from a longitudinal database. Patient age, sex, body mass index (BMI), number of previous surgeries, lesion localization, lesion size, symptom duration, as well as time and type of reoperation was extracted. A cox proportional-hazards model was applied to investigate the influence of baseline variables on risk of reoperation. Reoperation was defined as any type of subsequent ipsilateral knee surgery, excluding hardware removal. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was utilized to compare PROM between patients with and without reoperation. RESULTS: A total of 2039 patients were included with 1359 (66.7%) having a minimum follow-up of 24 months. There were overall 243 reoperations (prevalence 17.9%). Minor arthroscopic procedures (n = 96, 39.5%) and revision cartilage repair procedures (n = 78, 32.1%) were the most common reoperations. Nineteen patients (0.9%) reported conversion arthroplasty at 17.7 (10.4) months after ACI. Female sex (HR 1.5, 95% CI [1.2, 2.0], p = 0.002) and the presence of 1-2 previous surgeries (HR 1.5, 95% CI [1.1, 2.0], p = 0.010), or more than 2 previous surgeries (HR 1.9, 95% CI [1.2, 2.9], p = 0.004) were significantly associated with increased risk of reoperation following ACI. Significantly less patients surpassed the minimal clinically important difference (MCID) in the reoperation group at 24 months regarding the KOOS subscores pain (OR 1.6, 95% CI [1.1, 2.2]), quality of life (OR 2.2, 95% CI [1.6, 3.2]), symptoms (OR 2.0 [1.4, 2.9]), and sports (OR 2.0 [1.4, 2.8]). CONCLUSION: Female patients and individuals with a history of previous surgeries face an elevated risk of requiring reoperation after undergoing ACI, which is associated with failure to attain clinically relevant improvements. A thorough evaluation of the indications for ACI is paramount, particularly when patients have a history of previous surgeries. LEVEL OF EVIDENCE: Level III.

[The first decade of the DGOU's cartilage register-insights for clinical practice]. / Die erste Dekade des KnorpelRegisters der DGOU ­ Erkenntnisse für die klinische Praxis.

BACKGROUND: Registry data provide valuable epidemiological insights that help to further improve process and outcome quality in patient care. The German Cartilage Registry (KnorpelRegister DGOU) was established in 2013 as an instrument for quality assurance after surgical cartilage regenerative procedures on hip, knee and ankle joints. DATA COLLECTION: Participation in the German Cartilage Registry is optional for hospitals and practices. Currently, more than 160 institutions in Germany, Austria and Switzerland participate in the data collection. DATA COLLECTED AND INITIAL FINDINGS: The implementation of PROMs ("patient related outcome measurement"), as well as the recording of surgery-related influencing factors, enable a differentiated scientific analysis and represent a key quality feature of the registry. Initial analyses of the registry data have already provided clinically relevant findings for immediate patient care. For example, patients who underwent focal cartilage therapy prior to ACT show a clinically relevant, significantly worse outcome than patients who underwent primary ACT. First conclusions could also be drawn regarding the relevance of concomitant cartilage therapy. For example, in patients with focal cartilage damage of the medial knee joint compartment, registry data indicate that leg axis correction is indicated even in cases of mild deviation of the mechanical leg axis. CONCLUSION: The data and findings obtained from the Cartilage Registry represent an important aspect of clinical care research and serve as a complement to well-designed, clinically prospective cohort studies, RCTs, and meta-analyses.

Bipolar Lesions of the Knee Are Associated With Inferior Clinical Outcome Following Articular Cartilage Regeneration. A Propensity Score-Matched Analysis Including 238 Patients of the German Cartilage Registry (KnorpelRegister DGOU).

PURPOSE: To determine whether bipolar lesions (BL) are associated with inferior clinical outcome following articular cartilage regeneration (CR) compared to unipolar lesions (UL). METHODS: A registry-based study, including patients undergoing isolated CR for focal knee cartilage lesions was performed. Lesions were considered UL or BL depending on the opposing cartilage. Propensity score matching was applied to eliminate potential confounders. Two groups comprising 119 patients with similar baseline characteristics were matched. The Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, 6, 12, 24, and 36 months following CR served as primary outcome measure. KOOS improvement, reaching the minimal clinically important difference (MCID), KOOS subcomponents, and failure rates were calculated. RESULTS: Autologous chondrocyte implantation (ACI) was the most frequently performed procedure in both groups with 63.0% (BL) and 46.6% (UL). There was a significant difference regarding KOOS at 24 months between UL (76.39 ± 14.96) and BL (69.83 ± 18.83; P = .028), which did not exceed the threshold of MCID. No significant difference was detected at any other follow-up. KOOS improvement from baseline was lower in the BL group at all follow-ups and peaked at 36 months in both groups (UL [26.00 ± 16.12] vs. BL [16.63 ± 17.29]; P = .024). The failure rate in the BL group was higher at 8.2% (9/110) compared to the UL group at 3.9% (4/98) (P = .256). CONCLUSIONS: BL were associated with worse clinical outcome 2 years following CR compared to UL. However, both groups showed an ongoing clinical improvement up to 3 years postoperatively and a low failure rate. While inferior clinical improvement and a lower clinical response rate may be expected in BL patients, the observed differences do not justify excluding these patients from CR. LEVEL OF EVIDENCE: Level III, retrospective comparative prognostic trial.

Intracranial pressure monitoring following traumatic brain injury: evaluation of indications, complications, and significance of follow-up imaging-an exploratory, retrospective study of consecutive patients at a level I trauma center.

BACKGROUND: Measurement of intracranial pressure (ICP) is an essential part of clinical management of severe traumatic brain injury (TBI). However, clinical utility and impact on clinical outcome of ICP monitoring remain controversial. Follow-up imaging using cranial computed tomography (CCT) is commonly performed in these patients. This retrospective cohort study reports on complication rates of ICP measurement in severe TBI patients, as well as on findings and clinical consequences of follow-up CCT. METHODS: We performed a retrospective clinical chart review of severe TBI patients with invasive ICP measurement treated at an urban level I trauma center between January 2007 and September 2017. RESULTS: Clinical records of 213 patients were analyzed. The mean Glasgow Coma Scale (GCS) on admission was 6 with an intra-hospital mortality of 20.7%. Overall, complications in 12 patients (5.6%) related to the invasive ICP-measurement were recorded of which 5 necessitated surgical intervention. Follow-up CCT scans were performed in 192 patients (89.7%). Indications for follow-up CCTs included routine imaging without clinical deterioration (n = 137, 64.3%), and increased ICP values and/or clinical deterioration (n = 55, 25.8%). Follow-up imaging based on clinical deterioration and increased ICP values were associated with significantly increased likelihoods of worsening of CCT findings compared to routinely performed CCT scans with an odds ratio of 5.524 (95% CI 1.625-18.773) and 6.977 (95% CI 3.262-14.926), respectively. Readings of follow-up CCT imaging resulted in subsequent surgical intervention in six patients (3.1%). CONCLUSIONS: Invasive ICP-monitoring in severe TBI patients was safe in our study population with an acceptable complication rate. We found a high number of follow-up CCT. Our results indicate that CCT imaging in patients with invasive ICP monitoring should only be considered in patients with elevated ICP values and/or clinical deterioration.

Specific knowledge and resilience affect short-term outcome in patients following primary total hip arthroplasty.

PURPOSE: The aim of the present study was to investigate the potential associations between specific knowledge, resilience and patient-reported outcome measures (PROMS) following primary total hip arthroplasty (THA). METHODS: In a cross-sectional prospective study, consecutive patients following primary THA were included at a rehabilitation center. A novel knowledge score and the validated Connor Davidson Resilience Scale (CD-RISC) were utilized to assess patients' specific knowledge and resilience, respectively. Additionally, patients completed a qualitative questionnaire regarding the information they had received. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), as well as the University of California and Los Angeles Score (UCLA) served as primary outcome measures. Stepwise multiple regression analysis was performed to identify potential predictors of outcome. RESULTS: A total of 103 patients at a mean age of 67.5 years (SD 10.5, 38-88) were included in the analysis at a median of 55.5 days (IQR 43-81) following primary THA. The mean knowledge and resilience scores were 3.8 (SD 1.6, 0-7) and 69.5 (SD 18.5, 0-100), respectively. Forty-seven percent of patients were afraid of harming their prosthesis and these patients had up to 59% worse WOMAC scores (p < 0.001). WOMAC scores on admission to rehabilitation were predicted by resilience and knowledge scores (R2 = 0.106, p = 0.036). UCLA scores at the time of admission were predicted by knowledge scores (R2 = 0.078, p = 0.007). CONCLUSION: The present study demonstrated that patients with a feeling of uncertainty had an inferior short-term functional outcome following primary THA. Moreover, it could be shown that higher specific knowledge and resilience are associated with a better functional outcome according to validated PROMS. While these findings need to be prospectively validated in future studies, specific patient knowledge and resilience may have a direct impact on the outcome of primary THA.

Higher patient knowledge and resilience improve the functional outcome of primary total knee arthroplasty.

BACKGROUND: A significant percentage of patients have an unfavorable outcome following primary total knee arthroplasty (TKA). This study aimed to evaluate whether specific knowledge about the implant and resilience can influence the functional outcome following TKA. METHODS: A consecutive series of 163 patients following primary TKA at a mean age of 70 years (SD 9.1 years) were included at a regional rehabilitation center between December 2015 and December 2016. Specific patient knowledge (scale 0-7), Connor Davidson Resilience Scale (CD-RISC), Western Ontario and McMaster Universities (WOMAC) score, University of California and Los Angeles (UCLA) score and constitutional parameters were assessed on admission. Pearson's correlation analysis and stepwise linear regression analysis were performed to investigate associations between knowledge, resilience and functional scores. RESULTS: The mean overall knowledge score was 3.5 out of 7 and the mean resilience score was 72.9 out of 100. Mean WOMAC and UCLA scores on admission were 23.8 and 5.5, respectively. Stepwise linear regression analysis identified knowledge and age as significant predictors of WOMAC scores (R2 = 14.3%, p = 0.003). Knowledge and resilience were identified as significant predictors of UCLA scores (R2 = 13.8%, p = 0.013). CONCLUSION: This study highlights the importance of patient-related factors as part of an integral patient care concept in TKA. Although the identified predictors still need to be refined, it could be demonstrated how better patient knowledge might ultimately lead to better functional outcome following TKA. Routinely assessing patients' resilience might be a useful tool to identify patients at risk for low activity levels. LEVEL OF EVIDENCE: III. Patient-reported outcome study.

A risk stratification algorithm for lesions of uncertain malignant potential diagnosed by vacuum-assisted breast biopsy (VABB) of mammographic microcalcifications.

PURPOSE: To investigate a risk stratification strategy for lesions of uncertain malignant potential (B3) diagnosed by vacuum-assisted breast biopsy (VABB) of mammographic microcalcifications. METHODS: Patients who underwent VABB for microcalcification-only lesions with a diagnosis of B3 and subsequent surgery were included in this retrospective, IRB-approved study. Seventy-six B3-lesions (final histology: 66 benign, 10 malignant) were included (Tr). Data on B3 lesion type and presence of atypia, microcalcification characteristics (BI-RADS), removal at biopsy and concomitant lesions were collected. After univariate analysis (Chi-square test), data were combined into a risk stratification algorithm by using a ten-fold, cross-validated Classification and Regression Tree analysis (CRT). The algorithm was tested on a testing dataset (Te) of 23 B3-lesions (six malignant, 17 benign). RESULTS: Malignancy was more frequent in women with a concomitant cancer (P < 0.001) and highly suspicious microcalcifications (P < 0.001). The CRT algorithm retained three characteristics: morphology; presence of atypia; presence of concomitant cancer. The algorithm identified 25/76 (32.9 %,Tr) and 6/23 (26.1 %,Te) lesions at low risk of malignancy. No malignant cases were identified at surgery (0/31). There were 3/76 (3.9 %,Tr) and 1/23 (4.3 %,Te) lesions assigned as high-risk by the algorithm and confirmed at surgery (4/4). In the remaining lesions (48/76, 63.1 %,Tr; 16/23, 69.6 %,Te), malignancy rates varied between 9% and 88.4 %; thus, surgery could not have been avoided. CONCLUSION: We constructed and tested a risk stratification algorithm for B3 microcalcifications, including clinical, imaging, and pathological features, to assign probabilities of malignancy, which has the potential to reduce unnecessary surgeries.

Ramp lesions are frequently missed in ACL-deficient knees and should be repaired in case of instability.

PURPOSE: The aim of the current study was (1) to provide an overview of common definitions and classification systems of ramp lesions (RL) and (2) to systematically review the available literature with regard to the diagnosis and treatment of RLs in anterior cruciate ligament (ACL)-deficient knees. METHODS: Following the PRISMA guidelines, MEDLINE and Scopus were searched for articles (1) reporting on acute or chronic ACL injuries, (2) with concomitant medial meniscus injury, (3) located at the posterior meniscocapsular attachment site (and red-red zone). Ex vivo studies, reviews and technical notes were excluded. RESULTS: Twenty-seven studies were included based on the criteria mentioned above. RLs are common in ACL-deficient knees with a prevalence ranging from 9 to 24%. RLs should especially be suspected in younger patients, patients with an increased meniscal slope and in patients with prolonged time from injury to surgery. The sensitivity of MRI for the detection of RLs ranges from 48 to 86% at a specificity of 79-99%. For arthroscopy, RLs are easily missed through standard anterior portals (sensitivity 0-38%). RL repair leads to a significant improvement of subjective knee scores, regardless of the specific fixation technique. For stable RLs, the literature suggests equivalent postoperative stability for trephination and abrasion compared to surgical RL repair. CONCLUSION: Ramp lesions are frequently missed in ACL-deficient knees on standard arthroscopy with anterior portals only. If a RL is suspected, exploration via an additional posteromedial portal is indicated. In case of instability, RL repair should be performed. LEVEL OF EVIDENCE: IV.

Can we predict lesion detection rates in second-look ultrasound of MRI-detected breast lesions? A systematic analysis.

PURPOSE: To predict detection rates (DR) in second-look ultrasound of MRI-detected breast lesions by systematically combining clinical and anthropomorphic features. METHODS: A total of 104 suspicious breast-lesions, that were initially detected on breast MRI and underwent subsequent SLU from January 2013 through December 2013, were evaluated in this retrospective analysis. All images were reviewed by an experienced radiologist for this study. Both anthropomorphic, spatial and BI-RADS lesion features were recorded. Uni- and multivariate Classification and Regression Trees (CRT) statistics were used to predict SLU DR by these features. RESULTS: Among 104 MRI-detected lesions, 58 (55.8%) showed a correlate on SLU. In univariate analysis, homogeneous fatty or dense fibro-glandular-tissue-composition (FGT) as assessed by ultrasound, segmental non-mass-distribution pattern and small breast size as assessed by MRI were significantly associated with higher DR on SLU. The remaining BI-RADS features did not significantly affect SLU DR according to our data. The predictive model could stratify the likelihood of SLU correlates as high, intermediate and low according to FGT, lesion type, size and position. CONCLUSIONS: By systematically combining the features FGT, lesion type, size and position, we could predict SLU DR of MRI-detected breast lesions. This may help to decide the preferable method for lesion biopsy or follow-up in clinical practice.

Is breast MRI a helpful additional diagnostic test in suspicious mammographic microcalcifications?

PURPOSE: Microcalcifications are a common finding in mammography and usually require invasive procedures to diagnose or exclude malignancy. As many microcalcifications are due to benign lesions, we wanted to assess whether breast MRI as an additional diagnostic tool may be used to distinguish benign from malignant in this setting. MATERIALS AND METHODS: Eligible for this retrospective, IRB-approved observational study were 858 consecutive patients (mean age 54±11years) undergoing stereotactically-guided biopsies of suspicious mammographic microcalcifications during three year at our institution. Finally included were 152 patients who also underwent breast MRI <8weeks prior to biopsy. In case of malignant or lesions of uncertain malignant potential, subsequent surgery was performed. Benign findings were confirmed by imaging follow-up. BI-RADS category assignments from the original mammography and breast MRI reports were compared to the final diagnosis (benign vs. malignant) to determine diagnostic benchmarks. RESULTS: Histopathology revealed 81 benign (53.3%), 41 DCIS (27%) and 30 (19.7%) invasive cancers. Sensitivity, specificity, positive and negative predictive values for breast MRI were 97.2% (69/71), 39.5% (32/81), 58.5% (69/118) and 94.1% (32/34), respectively. Thus, 32/81 unnecessary biopsies in benign lesions (39.5%) may have been avoided, missing 2/71 malignant lesions (2.8%), both DCIS G2. CONCLUSION: Breast MRI as an additional diagnostic tool can be used to accurately distinguish benign from malignant mammographic microcalcifications and may thus be helpful to reduce unnecessary breast biopsies.