Dataset Information

Biobased polyester versus synthetic fiberglass casts for treating stable upper limb fractures in children: a randomized controlled trial.

ABSTRACT:

Background

Stable upper limb fractures, such as radius, ulna, or distal humerus fractures, are common pediatric orthopedic traumas that are traditionally managed with cast immobilization. The commonly used synthetic fiberglass cast is light and water resistant but may promote skin itchiness during casting, which is a common complaint of patients. In addition, these diisocyanate-based casts have been proven to be toxic and may cause asthma. Herein, we introduce a novel biobased polyester cast to compare its clinical outcomes and patient satisfaction with conventional synthetic fiberglass casts.

Methods

From Feb 2022 to Nov 2022, we undertook a single-center prospective randomized trial involving 100 children with cast-immobilized stable upper limb fractures. These patients were randomized into either biobased polyester or synthetic fiberglass groups. All patients were regularly followed up till the cast removal which occurred approximately 3-4 weeks after immobilizing. Objective clinical findings and subjective patient questionnaire were all collected and analyzed.

Results

According to the radiographs taken on the day of cast removal, there was no loss of reduction in both groups. The incidence of skin problems was 3.4 times higher in the synthetic fiberglass group than in the biobased polyester group. For the subjective questionnaire, the biobased polyester cast was preferred in every sub-item.

Conclusions

Our study strongly suggested that the novel biobased polyester cast provides matching stability to conventional fiberglass casts and improves patient satisfaction in an eco-friendlier and safer way.

Trial registration

ClinicalTrials.gov Protocol Registration and Results System ( https://www.

Clinicaltrials

gov/ ; ID: NCT06102603; Date: 26/10/2023).

SUBMITTER: Lan TY

PROVIDER: S-EPMC10759437 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Biobased polyester versus synthetic fiberglass casts for treating stable upper limb fractures in children: a randomized controlled trial.

Lan Tsung-Yu TY Chen Chin-Wen CW Huang Yu-Hao YH Lin Shang-Ming SM Liang Ching-Ting CT Chang Chih-Hung CH Rwei Syang-Peng SP

BMC musculoskeletal disorders 20240102 1

<h4>Background</h4>Stable upper limb fractures, such as radius, ulna, or distal humerus fractures, are common pediatric orthopedic traumas that are traditionally managed with cast immobilization. The commonly used synthetic fiberglass cast is light and water resistant but may promote skin itchiness during casting, which is a common complaint of patients. In addition, these diisocyanate-based casts have been proven to be toxic and may cause asthma. Herein, we introduce a novel biobased polyester ...[more]

PMID: 38166834

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Project description:More than 23 million tonnes of lignin are produced annually in the US from wood pulping and 98% of this lignin is burnt. Therefore, creating products from lignin, such as plastics, offers an approach for obtaining sustainable materials in a circular economy. Lignin-based copolymers were synthesized using a single pot, solvent free, melt condensation reaction. The synthesis occurred in two stages. In the first stage, a biobased prepolymer consisting of butanediol (BD, 0.8-1 molar content) and a diacid (succinic (SA), adipic (AA) and suberic acids (SuA), with varying amounts of diaminobutane (DAB, 0-0.2 molar content) was heated under vacuum and monitored by Fourier transform infra-red (FTIR) spectroscopy and electrospray ionization-mass spectrometry (ESI-MS). In the second stage, prepolymer was mixed with a softwood kraft lignin (0-50 wt.%) and further reacted under vacuum at elevated temperature. Progression of the polymerization reaction was monitored using FTIR spectroscopy. The lignin-copolyester/amide properties were characterized using tensile testing, X-ray diffraction (XRD), dynamic mechanical analysis (DMA), differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) techniques. Lignin co-polymer tensile (strength 0.1-2.1 MPa and modulus 2 to 338 MPa) properties were found to be influenced by the diacid chain length, lignin, and DAB contents. The lignin-copolymers were shown to be semi-crystalline polymer and have thermoplastic behavior. The SA based copolyesters/amides were relatively stiff and brittle materials while the AA based copolyesters/amides were flexible and the SuA based copolyesters/amides fell in-between. Additionally, > 30 wt.% lignin the lignin- copolyesters/amides did not exhibit melt behavior. Lignin-co-polyester/amides can be generated using green synthesis methods from biobased building blocks. The lignin- copolyesters/amides properties could be tuned based on the lignin content, DAB content and diacid chain length. This approach shows that undervalued lignin can be used in as a macromonomer in producing thermoplastic materials.

Project description:ImportanceTo date, there is currently no evidence-based medical support for the efficacy of topology-optimized splints in treating distal radius fractures.ObjectiveTo assess the clinical efficacy and complication rates of topology-optimized splints in the treatment of distal radius fractures after closed manual reduction.Design, setting, and participantsThis 12-week, multicenter, open-label, analyst-blinded randomized clinical trial (comprising a 6-week intervention followed by a 6-week observational phase) was carried out from December 3, 2021, to March 10, 2023, among 110 participants with distal radius fractures. Statistical analysis was performed on an intention-to-treat basis between June 3 and 30, 2023.InterventionParticipants were randomly assigned to 2 groups: the intervention group received topology-optimized splint immobilization and the control group received cast immobilization after closed manual reduction for 6weeks. After this period, immobilization was removed, and wrist rehabilitation activities commenced.Main outcomes and measuresThe primary outcome was the Gartland-Werley (G-W) wrist score at 6 weeks (where higher scores indicate more severe wrist dysfunction). Secondary outcomes encompassed radiographic parameters, visual analog scale scores, swelling degree grade, complication rates, and 3 dimensions of G-W wrist scores.ResultsA total of 110 patients (mean [SD] age, 64.1 [12.7] years; 89 women [81%]) enrolled in the clinical trial, and complete outcome measurements were obtained for 101 patients (92%). Median G-W scores at 6 weeks were 15 (IQR, 13-18) for the splint group and 17 (IQR, 13-18) for the cast group (mean difference, -2.0 [95% CI, -3.4 to -0.6]; P = .03), indicating a statistically significant advantage for the splint group. At 12 weeks, no clinically significant differences in G-W scores between the 2 groups were observed. Complication rates, including shoulder-elbow pain and dysfunction and skin irritation, were less common in the splint group (shoulder-elbow pain and dysfunction: risk ratio, 0.28 [95% CI, 0.08-0.93]; P = .03; skin irritation: risk ratio, 0.30 [95% CI, 0.10-0.89]; P = .02).Conclusions and relevanceFindings of this randomized clinical trial suggest that patients with distal radius fractures that were managed with topology-optimized splints had better wrist functional outcomes and fewer complications at 6 weeks compared with those who received casting, with no difference at week 12. Therefore, topology-optimized splints with improved performance have the potential to be an advisable approach in the management of distal radius fractures.Trial registrationChinese Clinical Trial Registry: ChiCTR2000036480.

Dataset Information

Biobased polyester versus synthetic fiberglass casts for treating stable upper limb fractures in children: a randomized controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Clinicaltrials

Publications

Biobased polyester versus synthetic fiberglass casts for treating stable upper limb fractures in children: a randomized controlled trial.

Similar Datasets

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