The aim of this study was to analyze primary flexor tendon repair results in zones I and II, comparing the rupture rate and clinical outcomes of the controlled active motion (CAM) protocol with the modified Kleinert/Duran (mKD) protocol.
Patients who underwent surgery with traumatic flexor tendon lacerations in zones I and II were divided in three groups according to the type of rehabilitation protocol and period of management: group 1 included patients who underwent CAM rehabilitation protocol with six-strand Lim and Tsai suture after May 2014. Group 2 and 3 included patients treated by six-strand Lim Tsai suture followed by a modified Kleinert/Duran (modK/D) protocol with additional place and hold exercises between 2003 and 2005 (group 2) and between 2011 and 2013 (group 3).
Strickland protocol pdf
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The gut feeling that lead to change in our rehabilitation protocol could be explained by the heterogenous bias. A precise outcome analysis of group 1 could underline that in patients with complex hand trauma, nerve reconstruction, oedema or early extension deficit, an even more intensive and individual rehabilitation has to be performed to achieve better TAM at 6 or 12 weeks. Our study explicitly demonstrated a significant better outcome in the modK/D group compared to CAM group. This monocenter study is limited by its retrospective nature and the low number of patients.
The functional results after flexor tendon repair in zones I and II remain a current topic of debate with regard to suture technique and the postoperative rehabilitation protocol. The dilemma of achieving a balance between reduction of scar formation without increasing risk of re-rupture is still unsolved. New developments in primary tendon repair in recent decades include stronger core tendon repair techniques, judicious and adequate venting of critical pulleys, followed by a combination of passive and active digital flexion and extension [1].
In an earlier publication, we demonstrated the benefit of a six-strand Lim Tsai suture followed by a modified Kleinert/Duran (modK/D) protocol with additional place and hold exercises over a two-strand suture technique combined with Kleinert/Duran rehabilitation alone [6].
For 7 years, the six-strand Lim/Tsai suture technique followed by the modK/D rehabilitation protocol was the standard treatment for flexor tendon repair in zone 1 and 2 in our clinic. After initial good results referring to rupture rate and range of motion (ROM) [6], an increase in the rate of secondary tendon rupture was noted in due course from 2011 to 2013. In this context, we questioned the use of another rehabilitation protocol to improve our results: the CAM rehabilitation protocol after flexor tendon repair was introduced by Small et al. [7] to improve postoperative range of motion by preventing restrictive adhesions.
The aim of this study was to clarify if the CAM protocol after primary flexor tendon repair in zones I and II lead to better outcomes compared to the modK/D protocol or if the gut feeling that lead to change in our surgical technique could be explained by heterogenous bias.
This clinical study was approved by our ethic committee (KEK: 2017-02095). Clinical and functional outcome from patients who underwent surgery with traumatic flexor tendon lacerations in zones I and II were assessed retrospectively. Inclusion criteria and exclusion criteria are reported in Table 1. Patients were divided in three groups according to the type of rehabilitation protocol and period of management: group 1 included patients who underwent CAM rehabilitation protocol after six-strand Lim and Tsai suture (Table 2). Group 2 and 3 included, respectively, patients treated by six-strand Lim Tsai suture followed by a modified Kleinert/Duran (modK/D) protocol with additional place and hold exercises between 2003 and 2005 [6] and between 2011 and 2013 (Table 2).
The aim of this study was to clarify if the CAM protocol in flexor tendon repair (zone I and II) lead to better outcomes compared to the modK/D protocol or if the gut feeling that lead to change in our surgical technique could be explained by the heterogenous bias. Rupture rate was 4.7% at 12 weeks in group 1 (3/63 flexor tendon repairs) compared to 2% (1/51 flexor tendon repairs) in group 2 and 8% in group 3 (7/86 flexor tendon repairs). The TAM in group 1 (113) was significantly worse than the TAM in group 2 (141) but with similar extension deficits in group 1 and 2. The assessment of range of motion by the original Strickland classification system resulted in 20% excellent and 15% good outcomes in the CAM group 1 compared with 42% and 36% in the modK/D group 2.
Despite reassuring results on rupture rate in the three groups of patients and precise analysis of the CAM protocol outcomes, these study present two limitations: first, it was not possible to make a statistical analysis in group 3 due to heterogeneous reasons. Moreover, it was a monocenter retrospective study limited by its number of patients.
The gut feeling that lead to change in our rehabilitation protocol could be explained by the heterogenous bias. A precise outcome analysis of group 1 could underline that in patients with complex hand trauma, nerve reconstruction, oedema or early extension deficit, an even more intensive and individual rehabilitation has to be performed to achieve better TAM at 6 or 12 weeks. Our study explicitly demonstrated a significant better outcomes in the modK/D group compared to CAM group. This monocenter study is limited by its retrospective nature and the low number of patients.
The protocol conforms to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines [16]. The SPIRIT checklist is provided as Additional file 1. The data collected at each time point will be as described in Table 1.
The surgeons will be trained in the administration technique, and a guide to the technique will be provided in each operating theatre. With the exception of the trial drug or active control, the pre-, intra- and post-operative analgesia regimes and management will follow local protocols. Peri-operative pain and rehabilitation pathways are not standardised across study sites. They vary across hospitals and may include a variety of regimens, including scheduled opioids and additional nerve blocks, per provider discretion.
All principal analyses will be undertaken on an intent-to-treat basis; that is, patients will be analysed as they are randomised, with sensitivity analyses being undertaken on the per-protocol population. The principal analyses will be performed for the available case dataset. For each outcome variable, patterns of missing data will be explored, and if there is a substantial amount of missing data on either of the dual primary outcomes, a sensitivity analysis using multiple imputation will explore the impact of missing data on the results.
The first patient was randomised to the trial in March 2018. Recruitment for the study is ongoing and is expected to finish in February 2020. This paper is based on the latest version of the protocol, v5 dated November 2018.
Monitoring for the study will be conducted centrally. On-site visits will only be triggered by events such as poor recruitment, data quality issues or high levels of safety issues and/or protocol deviations.
Early identification of developmental delays among young children is an important first step in providing the opportunity for children to receive early intervention services to increase functional skills. Parents of 21% of children reported being asked to complete a questionnaire about their child's development, indicating low use of validated screening tools. Although parents of twice as many children were informally asked about concerns they might have had about their child's learning, development, or behavior, this type of informal monitoring is less likely to result in appropriate identification of children with developmental delays. Substantial opportunities exist to help monitor the development of children in the United States, such as the use of protocols for developmental monitoring and the use of validated developmental screening tools as part of coordinated systems of health care.
Winning Friends and Influencing Dead People JL Strickland (bio) Click for larger view View full resolution Sitting up with the dead. Back when the dearly departed were routinely brought home for the wake, the protocol required that someone, usually male friends or relatives, sit up all night with the coffin after the visitors left so the deceased was not left alone while the grieving family slept. Flower-draped casket, Mississippi, glass negative, ca. 1930, Harris & Ewing Collection, Library of Congress.
Back when the dearly departed were routinely brought home for the wake, the protocol required that someone, usually male friends or relatives, sit up all night with the coffin after the visitors left so the deceased was not left alone while the grieving family slept.
BAS, MRH, JAM, JSR, and KG developed the questions investigated within the study. MRH, FJM, KG, BAS, JAM, NV, and JSR designed the sampling protocol. BAS, KG, JAM, NV, VP, and FJM conducted the fieldwork and collected the data. BAS analyzed the data. BAS, KG, FJM, JAM, NV, VP, JSR, and MRH interpreted the data and wrote the manuscript. All authors read and approved the final manuscript.
Research and animal procedures were conducted under the auspices of protocol #IACUC-15-044-CR01 from the Institutional Animal Care and Use Committee of Florida International University and in accordance with sampling permits #EVER-2015-SCI-0036 and #EVER-2017-SCI-0031 granted by Everglades National Park. 2ff7e9595c
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