C OPYRIGHTÓ2021BY T HE J OURNAL OF B ONE AN
D J OINT S URGERY,I NCORPORATED
Is Immobilization Necessary for Early Return to Work Following Distal Biceps Repair
Using a Cortical Button Technique?
A Randomized Controlled Trial
Joph W.Bergman,MD,PEng,FRCSC,Aneli Silveira,PT,MScRS,Robert Chan,MD,MSc,FRCSC, Michael Lapner,MD,FRCSC,Kevin A.Hildebrand,MD,FRCSC,Ian L.D.Le,MD,FRCSC, David M.Sheps,MD,MSc,MBA,FRCSC,Lauren A.Beaupre,PT,PhD*,and Aleem Lalani,MD,FRCSC* Investigation performed at the Western Upper Limb Facility,Sturgeon Community Hospital,St.Albert,Alberta;the University of Alberta,Edmonton,
学生学情分析范文Alberta;and the Peter Lougheed Centre,Calgary,Alberta,Canada
Background:Improvements in surgicalfixation to repair distal biceps tendon ruptures have not fully translated to earlier postoperative mobilization;it is unknown whether earlier mobilization affords earli
er functional return to work.This parallel-arm randomized controlled trial compared the impact of early mobilization versus6weeks of postoperative immobilization following distal biceps tendon repair.
Methods:One hundred and one male participants with a distal biceps tendon rupture that was amenable to a primary repair with u of a cortical button were randomized to early mobilization(lf-weaning from sling and performance of active range of motion as tolerated duringfirst6weeks)(n=49)or6weeks of immobilization(splinting for6weeks with no active range of motion)(n=52).Follow-up asssments were performed by a blinded asssor at2and6weeks and at3, 6,and12months.At12months,distal biceps tendon integrity was verified with ultrasound.The primary outcome was return to work.Secondary outcomes were pain,range of motion,strength,shortened Disabilities of the Arm,Shoulder and Hand questionnaire(QuickDASH)score,and tendon integrity.Intention-to-treat analysis was performed.A linear mixed model for repeated measures was ud to compare pain,range of motion,strength,and QuickDASH between the groups over time;return to work was assd with u of independent t tests.
建筑技术
Results:The groups were similar preoperatively(p‡0.16).The average age(and standard deviation)was44.7±8.6 years.Eighty-three participants(82%)were followed to12months.There were n
o differences between the groups in terms of return to work(p‡0.83).Participants in the early mobilization group had significantly more passive forearm supination (p=0.04),with passive forearm pronation(p=0.06)and active extension and supination(p=0.09)trending toward significantly greater range of motion in the early mobilization group relative to the immobilization group.Participants in the early mobilization group had significantly better QuickDASH scores over time than tho in the immobilization group(p=
0.02).There were no differences between the groups in terms of pain(p‡0.45),active range of motion(p‡0.09),or
strength(p‡0.70).Two participants(2.0%,1in each group)had full-thickness tears on ultrasound at12months(p=
0.61).Compliance was not significantly different between the groups(p=0.16).
形容辛苦的词语
Conclusions:Early motion after distal biceps tendon repair with cortical buttonfixation is well tolerated and does not appear to be associated with adver outcomes.No clinically important group differences were en.
Level of Evidence:Therapeutic Level I.See Instructions for Authors for a complete description of levels of evidence.
*Lauren A.Beaupre,PT,PhD,and Aleem Lalani,MD,FRCSC,contributed equally to this work.
Disclosure:The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article(/JBJS/G574).
A data-sharing statement is provided with the online version of the article(/JBJS/G575).
J Bone Joint Surg Am.2021;103:1763-71d dx.doi/10.2106/JBJS.20.02047
D istal biceps tendon ruptures occur most commonly
in young to middle-aged males1-3.The injuries are
usually caud by excessive eccentric loading4,which may result from a workplace injury1,4.Distal biceps tendon ruptures are typically treated surgically,with cortical button fixation gaining popularity after being described by Bain et al.5. Biomechanical studies have demonstrated that cortical button fi
xation is superior to other methods6,7.Improvements infixa-tion techniques may allow accelerated postoperative rehabilita-tion to afford earlier functional gains7,8and subquent return to work.Considering that the majority of people who experience distal biceps tendon ruptures are of working age,postoperative protocols affecting return to work warrant investigation9.
There is currently little connsus regarding postoperative immobilization following distal biceps tendon repair.Postop-erative immobilization protocols are highly variable,ranging from unrestricted motion with immediate lifting of as much as 20kg to immobilization for6weeks following distal biceps tendon repair10-18.Furthermore,early mobilization has only been described retrospectively14,15,17,18.Early mobilization following distal biceps tendon repair may allow earlier return to modified and full activities,including return to work9.Return to work,considered a valuable indicator of post-injury function19,conquently may enhance health and quality of life20.
Randomized controlled trials(RCTs)are needed to pro-vide evidence-bad optimization of postoperative rehabilitation and to elucidate the effects of early mobilization on return to work and other outcomes following distal biceps tendon repair. The primary objective of this RCTwas to compare the impact of early active movement postoperatively on time to return to work relative to6weeks of postoperative immobilization in males following distal biceps tendon repair.The conda
最诚恳道歉的句子ry purpo was to compare pain,function(range of motion,strength), health-related quality of life,and reruptures between groups.We hypothesized that earlier mobilization would allow earlier return to work without increasing adver outcomes.
Materials and Methods
Design
T his was a parallel-arm,single-blinded superiority RCT comparing2postoperative immobilization protocols for participants with a distal biceps tendon rupture that was amenable to primary repair with u of a cortical button. Acceptable primary repair was determined by the study sur-geons intraoperatively as requiring<60°of elbowflexion to allow the distal biceps tendon to be reattached to the radial tuberosity21.
Participants and Study Setting
Between2015and2018,male participants between18and65 years of age with a distal biceps tendon rupture that was amenable to primary surgical repair with u of a cortical button were eligible for inclusion.In order to be included, participants had to have been employed before the injury and had t
o be expected to return to work after the injury.Both work-related and non-work-related injuries were eligible.
The exclusion criteria were the prence of any identified abnormality in the morphology of the distal bicipital tuber-osity,previous distal biceps tendon repair,multi-trauma distal biceps tendon rupture,health conditions that precluded pro-viding informed connt,life expectancy of<2years,inability to understand and read the English language,or inability to return for follow-up.
The regional Health Ethics Rearch Board approved this trial(Pro00057067),which is registered v (NCT02505347).Consolidated Standards of Reporting Trials (CONSORT)guidelines22were followed in both the develop-ment and reporting of this trial.All participants provided signed informed connt preoperatively.
Operative Procedure
A cortical button,single-incision technique similar to that described by Bain et al.5was employed.Choice of cortical button manufacturer,suture size,and preci tendon suturing technique were at the discretion of the surgeon but in all cas included a metal cortical button and nonabsorbable core suture with a size of not less than#2.Surgical procedures were per-formed by1of
8upper-extremity fellowship-trained surgeons at2centers in Alberta,Canada.
Randomization
儿童减肥方法
Participants were randomized to early mobilization(lf-weaning from a sling and performance of active range of motion during thefirst6postoperative weeks)(n=49)or 6weeks of immobilization(splinting for6weeks postopera-tively with no active range of motion)(n=52).The ran-domization quence was computer-generated in blocks of 10,with a1:1group allocation.Randomization codes were stored in opaque quentially numbered envelopes and were opened immediately postoperatively by operating room staff when all eligibility criteria were confirmed.Following ran-domization,participants were provided written instructions bad on group allocation.
Group Allocation
Early Active Mobilization
Participants in the early mobilization group were instructed to move the elbow as tolerated postoperatively but to avoid generating>5lb(2.3kg)of force for thefirst6weeks postoperatively.Patients could wear a sling for comfort if needed.
Immobilization
Patients in the immobilization group wore a splint for 2weeks with the elbowflexed to90°and the forearm fully supinated.After2weeks,the splint could be removed5 times per day for passive elbowflexion,extension,pro-nation,and supination,with extension of the elbow ini-tially limited to approximately40°and then incread by approximately10°each subquent week.After the6-week postoperative asssment with the surgeon,the splint was discontinued.
Postoperative Protocols
In both groups,postoperative protocols mirrored tho typi-
cally ud by the surgeons and their colleagues and generally
were reprentative of published protocols.
Compliance
At6weeks postoperatively,all participants completed a ques-
tionnaire regarding splint u and daily activities in thefirst
6weeks(total duration,daily and nighttime splint u,arm
movement).Participants were unaware of the primary reason
for completing this questionnaire.Noncompliance was con-
sidered to have occurred if participants in the immobilization group performed active range of motion and did not wear the
splint or if participants in the early mobilization group wore
the sling full time and did not perform active range of motion
in thefirst6weeks after distal biceps tendon repair.Compli-
ance data were entered independently to maintain blinding of
the clinical asssor.All participants in both groups followed
the same rehabilitation protocol after6weeks.
Data Collection and Outcome Measures
Demographic data(age and x),patient-specific factors(working
status,Workers’Compensation status,dominant hand,recrea-tional activities,comorbidities),and duration of elbow symptoms
were collected at enrollment.Postoperatively,return to work,pain,
and shortened Disabilities of the Arm,Shoulder and Hand ques-
洗衣机龙头tionnaire(QuickDASH)scores were collected at2and6weeks and
漏断人初静
at3,6,and12months.Elbow range-of-motion measurements
commenced at6weeks,and elbow strength measurements com-
menced at3months;range of motion and strength were assd at
国产悍马all subquent follow-up visits by trained rearch associates who
were not involved in the participants’clinical care and were blinded
to group allocation.Musculoskeletal radiologists who were blinded
to treatment allocation evaluated distal biceps tendon integrity with u of ultrasound at12months after distal biceps tendon
repair.Complications/adver events,both medical and surgical,
were documented intraoperatively and at each asssment.
The primary outcome was time to return to work,which
was recorded as the time from thefirst misd day of work after
the injury to thefirst day of return to modified duties and the
time from thefirst misd day of work after the injury to the first day of return to full duties.Secondary outcomes were elbow pain,range of motion,strength,QuickDASH score,
distal biceps tendon integrity,and complications.Elbow pain
was assd with u of a visual analog scale(VAS),with0 reprenting no pain and10reprenting the worst possible pain23,24.Participants rated pain at rest,with activity,and at night.The VAS is a reli
able and valid method of measuring patient-reported pain;a minimum difference of20mm(20%) between groups was considered clinically important25,26.Elbow range of motion was measured with u of a universal goni-ometer in1°increments with standardized patient positioning, including active and passive elbowflexion and extension and forearm pronation and supination for both the affected and unaffected elbows.This method is a valid and reliable means of detecting changes in movement over time27.Elbow strength was measured with u of a handheld myometer for isometric elbow flexion and forearm supination strength with the participant’s arm in neutral(no abduction,the elbowflexed to90°,and the palm facing medially for supination).Peak values were recorded during each contraction,which was held for3conds.Strength values were expresd as raw values.The QuickDASH score was ud to asss health-related quality of life;this instrument is an11-item, patient-reported questionnaire that measures the function and psychosocial impact of upper-extremity musculoskeletal condi-tions28.The score ranges from0(no disability)and100(very disabled).The QuickDASH is widely ud in clinical practice and rearch as a valid,reliable,and responsive tool to measure patient-reported outcomes after upper-limb injuries28,29.The minimum important difference has been reported to be6.8points between groups30and8.0points over time within a single group31. Sample Size
The study was powered to detect a1-week difference in time to return to work between groups with b=0.10(power=0.9),a =0.05,and s=10;a total of88participants were required(44 per group).To allow for attrition over time,we enrolled101 participants.
Statistical Analysis
Statistical analysis was performed with u of intention to treat with all outcomes attributed to the assigned group;per-protocol analys were performed bad on compliance but are not reported as the findings were similar to intention-to-treat analys.Between-group comparisons of descriptive statistics ud independent t tests for continuous variables and chi-square or Fisher exact tests for cate-gorical variables.A linear mixed model for repeated measures was ud to compare pain,range of motion,strength,and QuickDASH scores between groups over time.Statistical analysis was performed with SPSS(version25.0;IBM),SAS(version9.4;SAS Institute),and R(version3.5.2;R Foundation for Statistical Computing),with the level of significance t at a=0.05.
Source of Funding
This study was funded by the Workers’Compensation Board of Alberta,the Edmonton Civic Employees’Charitable Assistance Fund,and the Sturgeon Community Hospital Foundation. Funding
sources providedfinancial support for imaging,study personnel,and administrative costs but did not contribute to study design,analysis,or interpretation.Surgeon investigators were notfinancially supported by study funds.
Results
B etween2015and2018,101male patients with a full-
thickness distal biceps tendon tear undergoing distal biceps tendon repair were enrolled,randomized,and retained in the study for follow-up and data analys;49patients were ran-domized to the early mobilization group,and52were ran-domized to the immobilization group.Eighty-three participants (82.2%)(including41in the early mobilization group and42 in the immobilization group)completed the asssment at 12months(Fig.1).
The groups were similar at the time of entry into the study (Table I).The average age (and standard deviation)was 44.7±8.6years.Eighty-ven participants (86.1%)worked full-time;59(58.4%)performed medium to heavy/very heavy work.The median time to surgery was 8.00days (interquartile range [IQR],6to 15days)and 7.00days (IQR,6to 15days)for the
early
Fig.1
Consolidated Standards of Reporting Trials (CONSORT)diagram of participant flow through this trial.
mobilization and immobilization groups,respectively.Partici-pants in the immobilization group reported lower compliance (31%noncompliant)compared with tho in the early mobili-zation group(17.5%noncompliant),although this difference was not significant(p=0.16).
Primary Outcome
Return to Work
The mean number of days to return to modified(p=0.83)or full work duties(p=0.94)was similar between groups.The mean return to modified duties was41.7days(95%confidence interval [CI],20.1to63.2days)for the early mobilization group and 38.1days(95%CI,11.9to64.3days)for the immobilization group.The mean return to full duties was88.0days(95%CI,64.8 to111.3days)for the early mobilization group and86.8days (95%CI,62.8to110.8days)for the immobilization group. Secondary Outcomes
Elbow Pain
Elbow pain at rest,with activity,and at night was not signifi-cantly different at any postoperative evaluation(p‡0.45).Both groups showed improvement over time(p<0.001)(Table II).Elbow Range of Motion
The early mobilization group had significantly better passive forearm supination(p=0.04)and trended toward better passive forearm pronation(p=0.06)and active supination and extension(p=0.09)compared with the immobilization group (Table II).Both groups improved over time(p£0.001).
Elbow Strength
Over12months,both groups had similar improvements in elbow flexion and supination strength(p‡0.70)(T able II).Compared with the uninjured side,the early mobilization group reached96% offlexion strength whereas the immobilization group achieved94%. Similarly,the early mobilization group attained94%of supination strength whereas the immobilization group attained91%relative to the uninjured side.No significant or clinically important differences were obrved between the groups in terms of strength.
QuickDASH
Both groups had improvement in QuickDASH scores over time(p<0.001).Overall,the early mobilization group had significantly better QuickDASH scores over time when com-pared with the immobilization group(p=0.02).However,
