The Pediatric Toronto Extremity Salvage Score (pTESS): Validation of a Self-reported Functional Outcomes Tool for Children with Extremity Tumors.

BACKGROUND: The physical function of children with sarcoma after surgery has not been studied explicitly. This paucity of research is partly because of the lack of a sufficiently sensitive pediatric functional measure. The goal of this study was to establish and validate a standardized measure of physical function in pediatric patients with extremity tumors. QUESTIONS/PURPOSES: (1) What is the best format and content for new upper- and lower-extremity measures of physical function in the pediatric population? (2) Do the new measures exhibit floor and/or ceiling effects, internal consistency, and test-retest reliability? (3) Are the new measures valid? METHODS: In Phase 1, interviews with 17 consecutive children and adolescents with bone tumors were conducted to modify the format and content of draft versions of the pediatric Toronto Extremity Salvage Score (pTESS). In Phase 2, the pTESS was formally translated into French. In Phase 3, 122 participants between 7 and 17.9 years old with malignant or benign-aggressive bone tumors completed the limb-specific measure on two occasions. Older adolescents also completed the adult TESS. Floor and ceiling effects, internal consistency, test-retest reliability, and validity were evaluated. RESULTS: Feedback from interviews resulted in the removal, addition, and modification of draft items, and the pTESS-Leg and pTESS-Arm questionnaires were finalized. Both versions exhibited no floor or ceiling effects and high internal consistency (α > 0.92). The test-retest reliability was excellent for the pTESS-Leg (intraclass correlation coefficient [ICC] = 0.94; 95% CI, 0.90-0.97) and good for the pTESS-Arm (ICC = 0.86; 95% CI, 0.61-0.96). Known-group validity (ability to discriminate between groups) was demonstrated by lower mean pTESS-Leg scores for participants using gait aids or braces (mean = 68; SD = 21) than for those who did not (mean = 87; SD = 11; p < 0.001). There was no significant difference between pTESS arm scores among respondents using a brace (n = 5; mean = 73; SD = 11) and those without (n = 22; mean = 83; SD = 19; p = 0.13). To evaluate construct validity, we tested a priori hypotheses. The duration since chemotherapy correlated moderately with higher pTESS-Leg scores (r = 0.4; p < 0.001) but not with pTESS-Arm scores (r = 0.1; p = 0.80), and the duration since tumor resection correlated moderately with higher pTESS-Leg scores (r = 0.4; p < 0.001) but not pTESS-Arm scores (r = 0.2; p = 0.4). Higher VAS scores (that is, it was harder to do things) antecorrelated with both pTESS versions (pTESS-Leg: r = -0.7; p < 0.001; pTESS-Arm: r = -0.8; p < 0.001). To assess criterion validity, we compared the pTESS with the current "gold standard" (adult TESS). Among adolescents, strong correlations were observed between the TESS and pTESS-Leg (r = 0.97, p < 0.001) and pTESS-Arm (r = 0.9, p = 0.007). CONCLUSIONS: Both pTESS versions exhibited no floor or ceiling effects and had high internal consistency. The pTESS-Leg demonstrated excellent reliability and validity, and the pTESS-Arm demonstrated good reliability and reasonable validity. The pTESS is recommended for cross-sectional evaluation of self-reported physical function in pediatric patients with bone tumors. LEVEL OF EVIDENCE: Level II, outcome measurement development.

Limb-sparing surgery with vascular reconstruction for malignant lower extremity soft tissue sarcoma.

BACKGROUND: The standard of care for lower extremity soft tissue sarcoma (STS) is limb-sparing surgery. A small subset of these patients will require concomitant vascular reconstruction to ensure adequate resection and to preserve limb viability and function. The aim of this study was to evaluate outcomes in these patients with respect to wound healing and postoperative functional status. METHODS: Outcomes for a total of 154 patients treated for malignant lower extremity STS during an 8-year period between 2005 and 2013 were entered in a prospective registry. Treatment was by medical management in 3 patients (2%), limb-sparing surgery with vascular reconstruction (LSVR) in 9 patients (6%), and limb-sparing surgery without vascular reconstruction (LS) in 142 patients (92%). The registry and patient records and the intraoperative records were consulted to determine the primary outcomes of patient survival and time for complete wound healing. The functional status of patients was assessed using the Musculoskeletal Tumor Society (MSTS) functional assessment score before surgery and at 6 and 12 months after surgery. RESULTS: Mean follow-up time was 74.7 months for the LSVR group and 53.4 months for the LS group. The mean time to complete wound healing was significantly longer in LSVR vs LS patients (88 days vs 34 days, respectively; P = .002), and overall survival was lower in LSVR patients (P = .01). Seven of the 9 LSVR patients required a total of 12 additional procedures to achieve wound healing, including 9 procedures to drain seromas (incision and drainage) with vacuum-assisted closure in 4 cases. Plastic surgery intervention was required in three patients, including one skin graft, one gracilis pedicle flap, and one vertical rectus abdominis myocutaneous flap. There was no significant difference in the mean MSTS scores preoperatively, at 6 months, and at 1 year after surgery between the two groups (27, 25, and 29 for LSVR vs 28, 31, and 31 for LS, respectively; P = .63, .11, and .67, respectively). CONCLUSIONS: The need for vascular reconstruction during limb-sparing surgery for lower extremity malignant STS is rare in a high-volume sarcoma center. Overall survival was lower in these patients, and the time to complete wound healing is prolonged and requires multiple secondary interventions. However, postoperative functional status as assessed by the MSTS is acceptable and comparable to that of patients not requiring vascular reconstruction.

Use of Ligament Advanced Reinforcement System tube in stabilization of proximal humeral endoprostheses.

AIM: To review outcomes following usage of the Ligament Advanced Reinforcement System (LARS(®)) in shoulder tumors. METHODS: Medical records of nineteen patients (19 shoulders) that underwent tumor excisional procedure and reconstruction with the LARS synthetic fabric, were retrospectively reviewed. RESULTS: Patients' median age was 58 years old, while the median length of resection was 110 mm (range 60-210 mm). Compared to immediate post-operative radiographs, the prosthesis mean end-point position migrated superiorly at a mean follow up period of 26 mo (P = 0.002). No statistical significant correlations between the prosthesis head size (P = 0.87); the implant stem body length (P = 0.949); and the length of resection (P = 0.125) with the position of the head, were found at last follow up. Two cases of radiological dislocation were noted but only one was clinically symptomatic. A minor superficial wound dehiscence, healed without surgery, occurred. There was no evidence of aseptic loosening either, and no prosthetic failure. CONCLUSION: LARS(®) use ensured stability of the shoulder following endoprosthetic reconstruction in most patients.

An anti-von Willebrand factor aptamer reduces platelet adhesion among patients receiving aspirin and clopidogrel in an ex vivo shear-induced arterial thrombosis.

The von Willebrand factor (vWF) aptamer, ARC1779 that blocks the binding of vWF A1-domain to platelet glycoprotein 1b (GPIb) at high shear, may deliver a site-specific antithrombotic effect. We investigated the efficiency of ARC1779 on platelet function in patients with coronary artery disease (CAD) on double antiplatelet therapy. Blood from patients taking aspirin and clopidogrel and from normal volunteers was treated ex vivo with ARC1779 or abciximab, either prior to perfusion (pretherapy) or 10 minutes following the initiation of perfusion (posttherapy) on damaged arteries. Under pre- but not posttherapy, platelet adhesion was significantly reduced by ARC1779 at 83 and 250 nmol/L and by abciximab (100 nmol/L) versus placebo (4.8, 3.8, and 2.9 vs 7.3 platelets × 10(6)/cm(2), P < .05). In contrast to abciximab, ARC1779 did not significantly affect platelet aggregation, P-selectin expression, and platelet-leukocyte binding. These proof-of-concept data may constitute the framework for randomized clinical investigations of this novel antiplatelet therapy among patients with CAD.