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1.
Injury ; 55(6): 111568, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38669890

ABSTRACT

IMPORTANCE: Most patients use a traditional socket prosthesis (TSP) to ambulate independently following transtibial amputation. However, these patients generally require prosthesis repairs more than twice annually and an entirely new prosthesis every two years. Furthermore, transtibial amputation patients have four times the skin ulceration rate of transfemoral patients, prompting more frequent prosthesis refitting and diminished use. Trans-Tibial osseointegration (TTOI) is a promising technique to address the limitations of TSP, but remains understudied with only four cohorts totaling 41 total procedures reported previously. Continued concerns regarding the risk of infection and questions as to functional capacity postoperatively have slowed adoption of TTOI worldwide. OBJECTIVE: This study reports the changes in mobility, quality of life (QOL), and the safety profile of the largest described cohort of patients with unilateral TTOI following traumatic amputation. DESIGN: Retrospective observational cohort study. The cohort consisted of patients with data outcomes collected before and after osseointegration intervention. SETTING: A large, tertiary referral, major metropolitan center. PARTICIPANTS: Twenty-one skeletally mature adults who had failed socket prosthesis rehabilitation, with at least two years of post-osseointegration follow-up. MAIN OUTCOMES AND MEASURES: Mobility was evaluated by K-level, Timed Up and Go (TUG), and Six Minute Walk Test (6MWT). QOL was assessed by survey: daily prosthesis wear hours, prosthesis problem experience, general contentment with prosthesis, and Short Form 36 (SF36). Adverse events included any relevant unplanned surgery such as for infection, fracture, implant loosening, or implant failure. RESULTS: All patients demonstrated statistically significant improvement post osseointegration surgery with respect to K-level, TUG, 6MWT, prosthesis wear hours, prosthesis problem experience, general prosthesis contentment score, and SF36 Physical Component Score (p < 0.01 for all). Three patients had four unplanned surgeries: two soft tissue refashionings, and one soft tissue debridement followed eventually by implant removal. No deaths, postoperative systemic complications, more proximal amputations, or periprosthetic fractures occurred. CONCLUSIONS AND RELEVANCE: TTOI is likely to confer mobility and QOL improvements to patients dissatisfied with TSP rehabilitation following unilateral traumatic transtibial amputation. Adverse events are relatively infrequent and not further disabling. Judicious use of TTOI seems reasonable for properly selected patients. LEVEL OF EVIDENCE: 2 (Therapeutic investigation, Observational study with dramatic effect).


Subject(s)
Amputation, Traumatic , Artificial Limbs , Osseointegration , Quality of Life , Tibia , Humans , Male , Female , Retrospective Studies , Adult , Middle Aged , Amputation, Traumatic/surgery , Amputation, Traumatic/rehabilitation , Follow-Up Studies , Tibia/surgery , Treatment Outcome , Prosthesis Design , Prosthesis Implantation
2.
BMJ Open ; 10(10): e038346, 2020 10 20.
Article in English | MEDLINE | ID: mdl-33082192

ABSTRACT

INTRODUCTION: Lower extremity amputation uniformly impairs a person's vocational, social and recreational capacity. Rehabilitation in traditional socket prostheses (TSP) is associated with a spectrum of complications involving the socket-residuum interface which lead to reduced prosthetic use and quality of life. Osseointegration has recently emerged as a novel concept to overcome these complications by eliminating this interface and anchoring the prosthesis directly to bone. Though the complications of TSPs affect both transfemoral and transtibial amputees, Osseointegration has been predominantly performed in transfemoral ones assuming a greater benefit/risk ratio. However, as the safety of the procedure has been established, we intend to extend the concept to transtibial amputees and document the outcomes. METHODS AND ANALYSIS: This is protocol for a prospective cohort study, with patient enrolment started in 2014 and expected to be completed by 2022. The inclusion criteria are age over 18 years, unilateral, bilateral and mixed transtibial amputation and experiencing socket-related problems. All patients receive osseointegrated implants, the type of which depend on the length of the residuum and quality of bone, which are press-fitted into the residual bone. Objective functional outcomes comprising 6-Minute Walk Test, Timed Up-and-Go test and K-level, subjective patient-reported-quality-of-life outcomes (Short Form Health Survey 36, daily prosthetic wear hours, prosthetic wear satisfaction) and adverse events are recorded preoperatively and at postoperative follow-up intervals of 3, 6, 12 months and yearly, and compared with the preoperative values using appropriate statistical tests. Multivariable multilevel logistic regression will be performed with a focus to identify factors associated with outcomes and adverse events, specifically infection, periprosthetic fracture, implant fracture and aseptic loosening. ETHICS AND DISSEMINATION: The Ethics approval for the study has been received from the University of Notre Dame, Sydney, Australia (014153S). The outcomes of this study will be disseminated by publications in peer-reviewed academic journals and scientific presentations at relevant orthopaedic conferences.


Subject(s)
Amputees , Adolescent , Australia , Humans , Osseointegration , Prospective Studies , Prosthesis Design , Quality of Life , Treatment Outcome
3.
Stem Cell Reports ; 10(1): 243-256, 2018 01 09.
Article in English | MEDLINE | ID: mdl-29290627

ABSTRACT

Transition from primed to naive pluripotency is associated with dynamic changes in transposable element (TE) expression and demethylation of imprinting control regions (ICRs). In mouse, ICR methylation and TE expression are each regulated by TRIM28; however, the role of TRIM28 in humans is less clear. Here, we show that a null mutation in TRIM28 causes significant alterations in TE expression in both the naive and primed states of human pluripotency, and phenotypically this has limited effects on self-renewal, instead causing a loss of germline competency. Furthermore, we discovered that TRIM28 regulates paternal ICR methylation and chromatin accessibility in the primed state, with no effects on maternal ICRs. Taken together, our study shows that abnormal TE expression is tolerated by self-renewing human pluripotent cells, whereas germline competency is not.


Subject(s)
DNA Methylation , DNA Transposable Elements , Genomic Imprinting , Mutation , Pluripotent Stem Cells/metabolism , Tripartite Motif-Containing Protein 28/genetics , Animals , Cell Line , Humans , Mice , Pluripotent Stem Cells/cytology , Tripartite Motif-Containing Protein 28/metabolism
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