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"Orthopedic Procedures"
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Role of closed drain after multi-level posterior spinal surgery in adults: a randomised open-label superiority trial
by
Prudnikova, Oksana Germanovna
,
Burtsev, Alexander Vladimirovich
,
Khomchenkov, Maxim Viktorovich
in
Back surgery
,
Blood
,
Bone surgery
2019
PurposeTo explore the role of closed suction drain in multi-level posterior spinal surgery.MethodsWe performed prospective, open-label, randomised control, superiority trial with parallel design and 1:1 allocation. A total of 161 patients undergoing posterior spinal surgery involving more than one motion segment at a dedicated spine surgery department were randomly allocated into “drain” or “no-drain” groups, based on which surgical drain was employed at the end of surgery. After excluding six cases with intraoperative dural tear, the data of 80 patients in “drain” and 75 patients in “no-drain” group were analysed. Primary outcome was total perioperative blood loss (sum of intraoperative blood loss, volume of drain if present and volume aspirated if patient developed collection in relation to surgical wound). The secondary outcomes were transfusion requirements, wound healing and complications.ResultsBoth groups were comparable with respect to baseline characteristics. Total perioperative blood loss was significantly higher in “drain” group (716 ± 312.97 ml vs 377.9 ± 295.72 ml, p < 0.0001). Number and volume of post-operative aspirations were significantly higher in “no-drain” group whereas transfusion requirements were significantly higher in “drain” group. Except for one case of superficial wound inflammation in either group, there were no complications. Subgroup analysis revealed that the results were applicable for surgeries involving “two/three” levels and “more than three” levels.ConclusionsThe practice of not using closed surgical drains after multi-level posterior spinal surgery reduces post-operative blood loss and transfusion requirements. But this comes with the disadvantage of increased wound soakage and need for post-operative wound aspirations. The risks of benefits of “drain” and “no drain” must be carefully weighed and an informed choice be taken.Graphical abstractThese slides can be retrieved under Electronic Supplementary Material.
Journal Article
Comparison of different immobilisation durations following open surgery for acute achilles tendon rupture: a prospective cohort study
by
Gao, Shan
,
Fan, Jixing
,
Lv, Yang
in
Achilles Tendon - injuries
,
Achilles Tendon - surgery
,
Achilles tendon rupture
2024
Background
In recent decades, early rehabilitation after Achilles tendon rupture (ATR) repair has been proposed. The aim of this prospective cohort study was to compare different immobilisation durations in order to determine the optimal duration after open surgery for ATR repair.
Methods
This study included 1088 patients (mean age, 34.9 ± 5.9 years) who underwent open surgery for acute ATR repair. The patients were categorised into four groups (A, B, C, and D) according to postoperative immobilisation durations of 0, 2, 4, and 6 weeks, respectively. All patients received the same suture technique and a similar rehabilitation protocol after brace removal,; they were clinically examined at 2, 4, 6, 8, 10, 12, 14, and 16 weeks postoperatively, with a final follow-up at a mean of 19.0 months. The primary outcome was the recovery time for the one-leg heel-rise height (OHRH). Secondary outcomes included the time required to return to light exercise (LE) and the recovery times for the range of motion (ROM). Data regarding the surgical duration, complications, the visual analogue scale (VAS) score for pain, the Achilles tendon Total Rupture Score (ATRS), and the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale score were also collected.
Results
The recovery times for OHRH, LE, and ROM were significantly shorter in groups A and B than in groups C and D (
P
< 0.001). The VAS scores decreased over time, reaching 0 in all groups by 10 weeks. The mean scores in groups A and B were higher than those in the other groups at 2 and 4 weeks (
P
< 0.001), whereas the opposite was true at 8 weeks (
P
< 0.001). ATRS and the AOFAS Ankle-Hindfoot scale score increased across all groups over time, showing significant between-group differences from weeks 6 to 16 (
P
< 0.001) and weeks 6 to 12 (
P
< 0.001). The mean scores were better in groups A and B than in groups C and D. Thirty-eight complications (3.5%) were observed, including 20 re-ruptures and 18 superficial infections. All complications were resolved at the last follow-up, with no significant between-group differences.
Conclusions
Immobilisation for 2 weeks after open surgery for ATR repair may be the optimal strategy for early rehabilitation with relatively minimal pain and other complications.
Trial registration
ClinicalTrials.gov (NCT04663542).
Journal Article
Clinical and cost-effectiveness of flexor digitorum profundus (FDP) versus FDP and flexor digitorum superficialis (FDS) repair for complete zone 2 flexor tendon injuries (FLARE): protocol for a randomised controlled trial
by
Gardiner, Matthew D.
,
Hira, Satwinder
,
Li, Jinshuo
in
Biomedicine
,
Cost analysis
,
Cost-Benefit Analysis
2025
Background
Flexor tendon injuries are common and lead to over 3200 admissions for specialist surgical repair annually in England and Wales. Surgery to repair complete division of both flexor tendons in zone 2 of the hand is technically challenging. There is variation in surgical repair techniques with no high-quality evidence to support decision-making. In particular, the decision to repair both tendons or just one is contested. Surgery is followed by specialist rehabilitation, which takes at least 12 weeks. The resulting hand function can impact the patient’s income, life satisfaction, well-being, self-worth, and mental health. The FLARE trial aims to determine the clinical and cost-effectiveness of repairing the flexor digitorum profundus (FDP) alone (intervention) versus the repair of both FDP and flexor digitorum superficialis (FDS) (control) for the treatment of complete zone 2, single-digit flexor tendon injuries in adults.
Methods
A multi-centre, two-arm, blinded, non-inferiority, parallel group, randomised controlled trial with an internal pilot, economic evaluation, and nested qualitative study. Participants will be randomised 1:1 to receive either repair of FDP alone or repair of both FDP and FDS. A total of 310 adults will be recruited from NHS Trusts within the UK, randomised at surgery, and followed up within 7 days, 6 weeks, 3 months, and 6 months post-randomisation. The primary outcome measure is the patient evaluation measure (PEM) administered 6 months post-randomisation. Secondary outcomes include the PEM at other timepoints, Patient Related Wrist/Hand Evaluation (PRWHE), EuroQol 5 Dimensions Score (EQ-5D-5L), complications, total range of motion, grip strength, adherence to splint and therapy regimens, work outcomes, treatment and outcome satisfaction, and healthcare resource use.
Discussion
FLARE is designed with sufficient power and rigour to provide evidence on the clinical and cost-effectiveness of two surgical repair methods for single-digit, complete zone 2 flexor tendon injuries in adults. If the repair of FDP alone is as beneficial to the patient as the repair of FDP and FDS, this could save the NHS £1.8 million annually through reduced time and material costs. Furthermore, the trial findings will facilitate better shared decision-making discussions between clinicians and patients.
Trial registration
ISRCTN 10918157. Prospectively registered: 12.01.2023.
Journal Article
Use of the National Surgical Quality Improvement Program in Orthopaedic Surgery
by
Obremskey, William T.
,
Blumer, Alexandra
,
Thakore, Rachel V.
in
Aged
,
Chi-Square Distribution
,
Communication
2015
Background
The goal of the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) is to improve patient safety. The database has been used by hospitals across the United States to decrease the rate of adverse events and improve surgical outcomes, including dramatic decreases in 30-day mortality, morbidity, and complication rates. However, only a few orthopaedic surgical studies have employed the ACS NSQIP database, all of which have limited their analysis to either single orthopaedic procedures or reported rates of adverse events without considering the effect of patient characteristics and comorbidities.
Question/purposes
Our specific purposes included (1) investigating the most common orthopaedic procedures and 30-day adverse events, (2) analyzing the proportion of adverse events in the top 30 most frequently identified orthopaedic procedures, and (3) identifying patient characteristics and clinical risk factors for adverse events in patients undergoing hip fracture repair.
Methods
We used data from the ACS NSQIP database to identify a large prospective cohort of patients undergoing orthopaedic surgery procedures from 2005 to 2011 in more than 400 hospitals around the world. Outcome variables were separated into the following three categories: any complication, minor complication, and major complication. The rate of adverse events for the top 30 orthopaedic procedures was calculated. Bivariate and multivariate analyses were used to determine risk factors for each of the outcome variables for hip fracture repair.
Results
Of the 1,979,084 surgical patients identified in the database, 146,774 underwent orthopaedic procedures (7%). Of the 30 most common orthopaedic procedures, the top three were TKA, THA, and knee arthroscopy with meniscectomy, which together comprised 55% of patients (55,575 of 101,862). We identified 5368 complications within the top 30 orthopaedic procedures, representing a 5% complication rate. The minor and major complication rates were 3.1% (n = 3174) and 2.8% (n = 2880), respectively. The most common minor complication identified was urinary tract infection (n = 1534) and the most common major complication identified was death (n = 850). An American Society of Anesthesiologists class of 3 or higher was a consistent risk factor for all three categories of complications in patients undergoing hip fracture repair.
Conclusions
The ACS NSQIP database allows for evaluating current trends of adverse events in selected surgical specialties. However, variables specific to orthopaedic surgery, such as open versus closed injury, are needed to improve the quality of the results.
Journal Article
Does intraoperative navigation improve the accuracy of pedicle screw placement in the apical region of dystrophic scoliosis secondary to neurofibromatosis type I: comparison between O-arm navigation and free-hand technique
2016
Purpose
To assess the accuracy of O-arm-navigation-based pedicle screw insertion in dystrophic scoliosis secondary to NF-1 and compare it with free-hand pedicle screw insertion technique.
Methods
32 patients with dystrophic NF-1-associated scoliosis were divided into two groups. A total of 92 pedicle screws were implanted in apical region (two vertebrae above and below the apex each) in 13 patients using O-arm-based navigation (O-arm group), and 121 screws were implanted in 19 patients using free-hand technique (free-hand group). The postoperative CT images were reviewed and analyzed for pedicle violation. The screw penetration was divided into four grades: grade 0 (ideal placement), grade 1 (penetration <2 mm), grade 2 (penetration between 2 and 4 mm), and grade 3 (penetration >4 mm).
Results
The accuracy rate of pedicle screw placement (grade 0, 1) was significantly higher in the O-arm group (79 %, 73/92) compared to 67 % (81/121) of the free-hand group (
P
= 0.045). Meanwhile, a significantly lower prevalence of grade 2–3 perforation was observed in the O-arm group (21 vs. 33 %,
P
< 0.05), and the incidence of medial perforation was significantly minimized by using O-arm navigation compared to free-hand technique (2 vs. 15 %,
P
< 0.01). Moreover, the implant density in apical region was significantly elevated by using O-arm navigation (58 vs. 42 %,
P
< 0.001).
Conclusion
We reported 79 % accuracy of O-arm-based pedicle screw placement in dystrophic NF-1-associated scoliosis. O-arm navigation system does facilitate pedicle screw insertion in dystrophic NF-1-associated scoliosis, demonstrating superiorities in the safety and accuracy of pedicle screw placement in comparison with free-hand technique.
Journal Article
Complications Associated With the Initial Learning Curve of Minimally Invasive Spine Surgery: A Systematic Review
by
Kim, Choll W.
,
Sclafani, Joseph A.
in
Bone Screws
,
Cervical Vertebrae - surgery
,
Clinical Competence
2014
Background
There is an inherently difficult learning curve associated with minimally invasive surgical (MIS) approaches to spinal decompression and fusion. The association between complication rate and the learning curve remains unclear.
Questions/purposes
We performed a systematic review for articles that evaluated the learning curves of MIS procedures for the spine, defined as the change in frequency of complications and length of surgical time as case number increased, for five types of MIS for the spine.
Methods
We conducted a systematic review in the PubMed database using the terms “minimally invasive spine surgery AND complications AND learning curve” followed by a manual citation review of included manuscripts. Clinical outcome and learning curve metrics were categorized for analysis by surgical procedure (MIS lumbar decompression procedures, MIS transforaminal lumbar interbody fusion, percutaneous pedicle screw insertion, laparoscopic anterior lumbar interbody fusion, and MIS cervical procedures). As the most consistent parameters used to evaluate the learning curve were procedure time and complication rate as a function of chronologic case number, our analysis focused on these. The search strategy identified 15 original studies that included 966 minimally invasive procedures. Learning curve parameters were correlated to chronologic procedure number in 14 of these studies.
Results
The most common learning curve complication for decompressive procedures was durotomy. For fusion procedures, the most common complications were implant malposition, neural injury, and nonunion. The overall postoperative complication rate was 11% (109 of 966 cases). The learning curve was overcome for operative time and complications as a function of case numbers in 20 to 30 consecutive cases for most techniques discussed within this review.
Conclusions
The quantitative assessment of the procedural learning curve for MIS techniques for the spine remains challenging because the MIS techniques have different learning curves and because they have not been assessed in a consistent manner across studies. Complication rates may be underestimated by the studies we identified because surgeons tend to select patients carefully during the early learning curve period. The field of MIS would benefit from a standardization of study design and collected parameters in future learning curve investigations.
Journal Article
Early mobilization does not reduce the risk of deep venous thrombosis after Achilles tendon rupture: a randomized controlled trial
by
Grävare Silbernagel, Karin
,
Heijne, Annette
,
Ackermann, Paul W.
in
Achilles tendon
,
Achilles Tendon - surgery
,
Adult
2020
Purpose
The hypothesis was that early functional mobilization would reduce the incidence of deep venous thrombosis (DVT) during leg immobilization after Achilles tendon rupture surgery. A secondary aim was to evaluate if the amount of weightbearing and daily steps influenced the risk of sustaining a DVT.
Methods
One-hundred and fifty patients with Achilles tendon rupture repair were randomized to treatment with early functional mobilization, encouraging full weightbearing and ankle motion in orthosis, or treatment-as-usual, i.e., 2 weeks of unloading in plaster cast followed by 4 weeks weightbearing in orthosis. At 2 and 6 weeks postoperatively, all patients were screened for DVT using compression duplex ultrasound. During the first 2 weeks postoperatively, patient-reported loading, pain and step counts were assessed.
Results
At 2 weeks, 28/96 (29%) of the patients in early functional mobilization group and 15/49 (31%) in the control group (n.s) had sustained a DVT. At 6 weeks, the DVT rate was 35/94 (37%) in the early functional mobilization and 14/49 (29%) in the control group (n.s). During the first postoperative week, the early functional mobilization group reported low loading and higher experience of pain vs. the control group (
p
= 0.001). Low patient-reported loading ≤ 50% (OR = 4.3; 95% CI 1.28–14.3) was found to be an independent risk factor for DVT, in addition to high BMI and higher age.
Conclusions
Early functional mobilization does not prevent the high incidence of DVT during leg immobilization in patients with Achilles tendon rupture as compared to treatment-as-usual. The low efficacy of early functional mobilization is mainly explained by postoperative pain and subsequent low weightbearing. To minimize the risk of DVT, patients should be encouraged to load at least 50% of body weight on the injured leg 1 week after surgery.
Level of evidence
Therapeutic, level 1
Journal Article
The Effectiveness and Safety of Utilizing Mobile Phone–Based Programs for Rehabilitation After Lumbar Spinal Surgery: Multicenter, Prospective Randomized Controlled Trial
2019
Rehabilitation is crucial for postoperative patients with low back pain (LBP). However, the implementation of traditional clinic-based programs is limited in developing countries, such as China, because of the maldistribution of medical resources. Mobile phone-based programs may be a potential substitute for those who have no access to traditional rehabilitation.
The aim of this study was to examine the efficacy of mobile phone-based rehabilitation systems in patients who underwent lumbar spinal surgery.
Patients who accepted spinal surgeries were recruited and randomized into 2 groups of rehabilitation treatments: (1) a mobile phone-based eHealth (electronic health) program (EH) or (2) usual care treatment (UC). The primary outcomes were (1) function and pain status assessed by the Oswestry Disability Index (ODI) and (2) the visual analog scale (VAS). Secondary outcomes were (1) general mental health and (2) quality of life (Likert scales, EuroQol-5 Dimension health questionnaire, and 36-item Short-Form Health Survey). All the patients were assessed preoperatively and then at 3, 6, 12, and 24 months postoperatively.
A total of 168 of the 863 eligible patients were included and randomized in this study. Our analysis showed that the improvement of primary outcomes in the EH group was superior to the UC group at 24 months postoperatively (ODI mean 7.02, SD 3.10, P<.05; VAS mean 7.59, SD 3.42, P<.05). No significant difference of primary outcomes was found at other time points. A subgroup analysis showed that the improvements of the primary outcomes were more significant in those who completed 6 or more training sessions each week throughout the trial (the highest compliance group) compared with the UC group at 6 months (ODI mean 17.94, SD 5.24, P<.05; VAS mean 19.56, SD 5.27, P<.05), 12 months (ODI mean 13.39, SD 5.32, P<.05; VAS mean 14.35, SD 5.23, P<.05), and 24 months (ODI mean 18.80, SD 5.22, P<.05; VAS mean 21.56, SD 5.28, P<.05).
This research demonstrated that a mobile phone-based telerehabilitation system is effective in self-managed rehabilitation for postoperative patients with LBP. The effectiveness of eHealth was more evident in participants with higher compliance. Future research should focus on improving patients' compliance.
Chinese Clinical Trial Registry ChiCTR-TRC-13003314; http://www.chictr.org.cn/showproj.aspx?proj=6245 (Archived by WebCite at http://www.webcitation.org/766RAIDNc).
Journal Article