Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation.
The aim of this study was to compare the long-term (i.e. >5 years ...postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery.
The present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS).
After >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05-3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups.
In conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures.
http://controlled-trials.com ISRCTN44212338.
The Current State of Meniscus Replacements van Minnen, B. S.; van Tienen, T. G.
Current reviews in musculoskeletal medicine,
05/2024, Letnik:
17, Številka:
8
Journal Article
Recenzirano
Odprti dostop
Purpose of Review
The field of meniscus replacement is changing continuously, with new devices emerging and others disappearing from the market. With the current tendency to preserve the knee joint, ...meniscus implants may become more relevant than ever. The purpose of this review is to provide an overview of the current state of partial and total meniscus replacements that have been developed beyond the academic phase. The available clinical and pre-clinical data is evaluated, and omissions are identified.
Recent Findings
Recent systematic reviews have shown a lack of homogenous clinical data on the CMI and Actifit meniscal scaffolds, especially regarding long-term performance without concomitant surgical interventions. Clinical studies on the medial total meniscus prostheses NUsurface and Artimis are ongoing, with the NUsurface being several years ahead. New techniques for meniscus replacement are rapidly developing, including the Artimis lateral meniscus prosthesis and the MeniscoFix 3D-printed scaffold.
Summary
All evaluated clinical studies point towards improved clinical outcomes after implantation of partial and total meniscus replacements. Long-term data on survival and performance is of low quality for CMI and Actifit and is unavailable yet for NUsurface and Artimis. It is of major importance that future research focuses on optimizing fixation methods and identifying the optimal treatment strategy for each patient group. New techniques for total and partial replacement of the medial and lateral meniscus will be followed with interest.
The aim of this systematic review was to compare patient-reported outcomes after harvesting calvarial or anterior iliac crest bone grafts to repair severe jaw defects and enable implant placement. ...The MEDLINE, Embase, Cochrane Central Register of Controlled Trials databases, and OpenGrey were searched for studies on patient satisfaction, pain, disturbances in daily functioning, sensory alterations, donor site aesthetics, and complication rates. Of the 1946 articles identified, 43 reporting 40 studies fulfilled the inclusion criteria; the studies were one randomized controlled clinical trial, one retrospective controlled clinical trial, and 23 prospective and 15 retrospective cohort studies. A meta-analysis of two studies (74 patients) showed no difference in satisfaction (mean difference (MD) − 0.13, 95% confidence interval (CI) − 1.17 to 0.92; P = 0.813) or postoperative pain (directly postoperative: MD −2.32, 95% CI −5.20 to 0.55, P = 0.113; late postoperative: MD −0.01, 95% CI −0.14 to 0.11, P = 0.825) between donor sites. However, the level of evidence is limited, due to the retrospective, non-randomized design of one study. Postoperative gait disturbances were highly prevalent among the anterior iliac crest patients (28–100% after 1 week). The incidence rates of sensory disturbances and other complications were low, and the donor site aesthetic outcomes were favourable for both graft types. To conclude, harvesting bone grafts from the calvarium or anterior iliac crest to augment the severely resorbed edentulous jaw results in similar patient satisfaction. However, the findings for postoperative pain and disturbances in daily living suggest a trend in favour of calvarial bone grafts if harvested using an adjusted technique.
The aim of this study was to perform a systematic review of the literature on the temporomandibular joint (TMJ) prosthesis as a treatment option after mandibular condyle fracture. Three databases ...were searched (PubMed, Embase, Cochrane Library) and 2670 unique papers were identified. A total of 337 studies were included (121 case reports, 89 case series, and 127 cohort/clinical studies). In total 14,396 patients and 21,560 prostheses were described. Of the 127 cohort or clinical studies, 100 (79%) reported inclusion criteria, 54 (43%) reported exclusion criteria, and 96 (76%) reported the inclusion period. The base population from which patients were recruited was reported in 57 studies (45%). The reason for TMJ prosthesis implantation was reported for 4177 patients (29.0%). A history of condylar fracture was present in 83 patients (2.0%); a history of mandibular trauma was present in 580 patients (13.9%). The meta-analysis showed a pooled prevalence of condylar fracture of 1.6% (95% confidence interval 0.9–2.4%) and a pooled prevalence of trauma or condylar fracture of 11.3% (95% confidence interval 7.1–16.0%). Heterogeneity was highly significant (P < 0.001). The TMJ prosthesis appears to be reserved for patients with persistent pain, bony or fibrous ankylosis, or osteomyelitis after primary closed or open treatment of fractures of the mandibular condyle.
Titanium osteosynthesis is currently the fixation system of choice in maxillofacial traumatology. Biodegradable osteosynthesis systems have the ability to degrade in the human body. The aim of this ...study was to conduct a systematic review, with meta- and trial sequential analyses, to assess the efficacy and morbidity of biodegradable versus titanium osteosynthesis after maxillofacial trauma. MEDLINE, Embase, and CENTRAL were searched for randomized controlled trials and prospective and retrospective controlled studies. Five time periods were studied: perioperative, short-term (0–4 weeks), intermediate (6–12 weeks), long-term (>12 weeks), and overall follow-up. After screening 3542 records, 24 were included. All had a high risk of performance and detection bias due to the nature of the interventions. Meta-analysis showed no differences in efficacy or morbidity between biodegradable and titanium osteosynthesis. The risk of perioperative screw breakage was significantly higher (risk ratio 17.13, 95% confidence interval 2.19–34.18) and the symptomatic plate removal rate lower in the biodegradable group (risk ratio 0.11, 95% confidence interval 0.02–0.57), which was confirmed by the trial sequential analysis. The quality of evidence ranged from very low to moderate. Based on the narrative review and meta-analyses, current evidence shows that biodegradable osteosynthesis is a viable alternative to titanium osteosynthesis when applied in the treatment of maxillofacial trauma, with similar efficacy but significantly lower symptomatic plate removal rates. Perioperative screw breakage occurred significantly more often in the biodegradable group compared to the titanium group.
Purpose
The purpose of this first-in-human study was to evaluate the effect of a polycarbonate anatomical meniscus prosthesis system, including the surgical procedure, on knee pain and describe ...potential adverse events in patients with post-meniscectomy pain syndrome.
Methods
Eleven patients with post-meniscectomy pain syndrome and limited underlying cartilage damage were enrolled in the study. Five received a medial polycarbonate urethane meniscus prosthesis which was clicked onto 2 titanium screws fixated at the native horn attachments on the tibia. The KOOS score was planned to be collected at baseline and at 3, 6, 12 and 24 months following the intervention including radiographs at 6, 12 and 24 months. MRI scans were repeated after 12 and 24 months.
Results
The surgical technique to select an appropriately sized implant and correct positioning of the fixation screws and meniscus prosthesis onto the tibia was demonstrated to be feasible and reproducible. Inclusion stopped after 5 patients because of serious adverse device-related events. All patients reported knee joint stiffness and slight effusion in their knee at 6 months follow-up. In 3 patients the implant was removed because of implant failure and in 1 patient the implant was removed because of persistent pain and extension limitation. In none of the patients did the KOOS score improve in the first 6 months after surgery. However, in the patient who still has the implant in situ, PROMs started to improve 1 year after surgery and this improvement continued through 2 years of follow-up. The KOOS Pain, symptoms and ADL were close to the maximal 100 points. KOOS QoL and sport did improve but remained suboptimal.
Conclusion
This first version of the meniscus prosthesis led to impaired knee function and failed in four out of five patients. The patients where the prosthesis was removed were salvable and the PROMs returned to pre-study levels. The results in the patient where the device is still in place are promising.
Level of evidence
Level II.
Autogenous bone graft harvesting is still commonly considered the gold standard for the reconstruction of a severely resorbed maxillary alveolar ridge; however, the preferred donor site remains a ...subject of debate. This study compared the morbidity of calvarial and iliac crest donor sites after harvesting. Twenty edentulous patients with an insufficient volume of maxillary bone for reliable implant placement were assigned randomly to either calvarial (n=10) or anterior iliac crest (n=10) bone harvesting groups. All patients underwent a maxillary sinus floor elevation procedure combined with widening of the alveolar process using buccal bone blocks. Donor site morbidity was assessed before, during, and at 1year after the surgery through patient questionnaires, physical examination, and medical records. No perioperative complications occurred. The anterior iliac crest group reported minor postoperative pain after harvesting. The scars after calvaria harvesting were significantly longer (P=0.003), but this was not bothersome for the group of patients. Long-term pain was negligible and satisfaction was high in both groups. Both the calvaria and anterior iliac crest are associated with low long-term donor site morbidity and high patient satisfaction. Thus, patient-centred decision-making is appropriate when selecting the preferred harvesting method for that patient.
This systematic review and meta-analysis was performed to critically assess the methodological quality of the existing systematic reviews, and to evaluate the postoperative complications of the ...mandibular fractures treated with locking and non-locking plate systems. An electronic search was conducted in PubMed, Embase, Web of Science, Cochrane library’s electronic databases and grey literate using a combination of Medical Subject Heading terms and key words, until September 2018. No restrictions were applied to the search strategy. In total, three relevant systematic reviews were included, and the quality of these studies was low. A total of 33 studies (20 randomized studies and 13 non-randomized studies) were included in this systematic review, and 16 of them were included in meta-analysis. Most of the included randomized studies had an unclear risk of bias (Cochrane Collaboration); the quality of non-randomized studies ranged between 6 and 17 (Methodological Index for Non-Randomized Studies − MINORS). Based on the results of our meta-analysis, we conclude that locking plates are superior only with respect to the need for mandibulomaxillary fixation (MMF) in the early postoperative period.
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