Delayed return to work after volar or combined plating of type C distal radius fracture: a secondary analysis of a randomised clinical trial

doi:10.21203/rs.3.rs-4682745/v1

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Research Article

Delayed return to work after volar or combined plating of type C distal radius fracture: a secondary analysis of a randomised clinical trial

https://doi.org/10.21203/rs.3.rs-4682745/v1

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Background

Distal radius fracture (DRF) is the most common of fractures, accounting for 18% of all fractures in orthopaedic trauma units. The ability to return to work is an important outcome for both society and the individual, but there is a large variation among patients in how much time off work is required. The choice of treatment is likely an important factor.

Methods

This study was a secondary analysis of an earlier published randomised clinical trial comparing volar locking plate fixation with combined dorsal and volar plate fixation of AO type C DRF. In the present study, we examined the risk of requiring more than 3 months of sick leave among patients who were in the workforce at the time of fracture.

Results

Of the 84 cases included in this analysis, 10 had a delayed return to work. There was a statistically significant risk of delayed return to work when combined plating was used as the surgical method, with an odds ratio of 7.454 (95% confidence interval: 1.362–40.804, p = 0.021) in the final multivariate analysis.

Conclusions

Sick leave is an important contributor to total costs in patients with DRF, and more invasive treatments like combined plating are associated with longer sick leave. Our results indicate a higher risk of delayed return to work in the combined plating group, possibly due to more extensive soft tissue dissection. We recommend a restrictive use of combined plating.

Trial registration:

The study was registered in the Swedish research database FoU in Sweden (registration number: 274674) on the 4th of August 2020.

distal radius fracture

patient-related outcome measures

plating

wrist function

sick leave

rehabilitation

health economics

The most common fracture in the adult population is the distal radius fracture (DRF), which has an incidence of 278 fractures per 100,000 person-years and accounts for 18% of all fractures in orthopaedic trauma units.(1, 2) Orthopaedic trauma is associated with socioeconomic impact for the patient and society, and the mean length of absence from work following a DRF is about 90 days.(3) However, there is significant variability in patients’ needs, with 21–31% requiring no time off work at all.(4, 5) The most important factors associated with a long absence from work include high levels of pain, poor self-assessed disability 1 week after treatment, need for surgical treatment, and high occupational demands.(4, 5) High age and an initially displaced fracture are also risk factors.(4) Educational level does not affect the length of absence from work when corrected for occupational demands.(4, 5) All upper extremity fractures, including DRF, require more time absent from work than finger fractures; but one study found that for all upper extremity fractures, socioeconomic factors such as lack of fixed employer and feeling economic distress were associated with unsuccessful return to work within 90 days.(6) To our knowledge, no studies have assessed the influence of severity of the fracture or type of surgery in relation to return to work for patients with a DRF.

During the normal course following DRF, severe symptoms recede in 2 months, and only minimal pain and disability are present at 6 months.(7) Although the majority of patients recover with good function, 17% still have major disabilities 1 year after a fracture.(8) Complications following surgical treatment may delay this recovery significantly, and interference with tendons, tendon irritation, and the need for hardware removal are commonly described problems with volar and combined plating.(9, 10) Today, about 50% of Arbeitsgemeinschaft für Osteosynthesefragen (AO) type C DRFs are treated surgically, most commonly with volar plating.(11–13) A meta-analysis of trials comparing non-operative treatment to volar locking plate, in which the majority of fractures were AO type C DRF, demonstrated that volar plating in these patients led to improved function at 3 months, 6 months, and 12–24 months after fracture.(14) However, in some complex cases of the most comminuted AO type C DRF, a volar plate alone may not provide sufficient stability.(15)

We have previously published a randomised clinical trial (RCT) comparing volar locking plate fixation with combined dorsal and volar plate fixation of AO type C DRF. We found significantly better patient-reported outcomes, grip strength, and range of motion (ROM) in the volar plate locking plate group, but the between-group difference in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score was smaller than the minimal clinically important difference. No difference in radiological outcomes was found.(16)

Since combined plating is associated with more extensive soft tissue dissection, longer operating time, and an increased risk of infection,(17, 18) we hypothesised that it could also be associated with an increased risk of delayed return to work. This study aimed to investigate whether combined plating was associated with an increased risk of delayed return to work compared to volar plating.

This was a secondary analysis of a previously published RCT. The study sample consisted of adult patients (≥18 years) with AO type C fractures treated at Örebro University Hospital, a tertiary referral hospital, between June 2017 and July 2019. Inclusion and exclusion criteria are listed in Table 1. The study was approved by the regional ethical committee (ref: 2016 − 455), and the study was registered in the Swedish research database FoU in Sweden (registration number: 274674). All patients gave written informed consent before participation according to the Helsinki Declaration.(19)

Table 1

Inclusion and exclusion criteria.
Inclusion criteria	Exclusion criteria
Age 18–80 years	Previous fracture of the same wrist
Operation within 12 days of injury	Bilateral fractures
AO type C with one or more of the following:	Other concomitant fractures
> 20° dorsal angulation of the distal radial articular surface	Open fracture
	Fracture extending to the diaphysis
> 2 mm ulnar plus
	Ongoing chemotherapy or radiotherapy
	Metabolic diseases that affect bone
	Dementia
	Mental illness
	Alcohol misuse disorder or opiate addiction
	Difficulty understanding Swedish
	Severe neurological disease
	Severe cardiopulmonary disease
	Not in workforce at time of injury
AO = Arbeitsgemeinschaft für Osteosynthesefragen.

A total of 150 patients (n = 75 in each group) were randomized to open reduction and fixation using a volar locking plate (TriMed) or combined plating with a volar T-plate and a low-profile dorsal plate with variable angle locking screws (TriMed). All surgeries were performed by specialists in hand surgery. The patients were randomized using sealed opaque envelopes containing the study number and surgical technique, which were opened prior to surgery by the operation room nurse.

The sample size for the original study was calculated on the basis of the QuickDASH score. A sample size of 63 patients in each group available at the 1-year follow-up was considered the minimum to detect a 10-point difference in the QuickDASH score at a significance level of p = .05 and a common standard deviation of 20 points with 80% power. With an estimated dropout of approximately 20%, the sample size was set to 150 patients. A post-hoc power analysis for this secondary analysis demonstrated a 73% power for the detection of a 10% increase in risk of delayed return to work.

Surgical technique

All surgeries were performed under combined brachial plexus block and general anaesthesia. A tourniquet was used. A volar central incision was made to expose the volar ulnar portion of the distal radius, and the carpal tunnel was opened.(20) The volar portion was visualized between the finger flexors ulnarly, the median nerve, and the thumb flexor radially. The pronator quadratus was divided with a central split, and the volar cortex was reduced. The volar plate was placed, and the pronator quadratus was repaired using resorbable sutures when possible. This surgical approach was clinical routine for AO type C DRFs at the time of the study.

In the combined plating group, an additional dorsal longitudinal incision was made. This was placed centrally over Lister’s tubercle. The fracture was dorsally exposed through the fourth extensor compartment, following the division of the extensor retinaculum and subperiosteal dissection. Impacted fracture fragments were reduced and the dorsal plate was fixated starting proximately and going distally.

If an associated ulnar styloid fracture was present, the stability of the distal radioulnar joint (DRUJ) was assessed after plate fixation of the DRF. DRUJ instability was treated with reduction and fixation of the styloid with either a 3.0-mm cannulated screw (DePuy Synthes) or a 2.0-mm locking ulna hook plate (DePuy Synthes). (Fig. 1)

Antibiotic prophylaxis (intravenous cloxacillin 2 g, or in case of intolerance to β-lactam antibiotics, clindamycin 600 mg) was used if the duration of surgery exceeded 2 hours or if wounds were present in or near the surgical field.

Postoperative care

All patients were given instructions on active finger ROM exercises and oedema control by an experienced hand therapist on the first postoperative day. A cast was applied for 2 weeks. At 2 weeks postoperatively, the cast was replaced with an orthosis which was removed for active wrist and finger ROM exercises with a maximum load of 1 kg. The load was gradually increased, and the orthosis was removed 4 weeks postoperatively.

Clinical evaluation

At the 1-year follow-up, a hand therapist performed clinical measurements including ROM, hand grip strength, visual analogue scale (VAS) pain scores, and patient-reported outcome measurements. Both the Patient-Rated Wrist Evaluation (PRWE) score and the short version of the QuickDASH questionnaire were used in validated Swedish translations.(21, 22) The PRWE is a 15-item questionnaire used to calculate a score of 0–100, where 0 represents no pain or disability in activities of daily living. The QuickDASH questionnaire evaluates a patient’s upper-extremity disability during the past week. A score of 0–100 is calculated from an 11-item questionnaire, where 100 represents the most severe disability and symptoms.

Wrist ROM, including flexion, extension, radial deviation, ulnar deviation, and pronation and supination (degrees), was evaluated using a goniometer according to the Swedish National Quality Registry for Hand Surgery guidelines.(23) Hand grip strength (in kg) was measured with a Jamar Hand Dynamometer (Biometrics Ltd) in handle position 2. The mean value of 3 measurements was calculated.(23) For right-handed patients, correction of grip strength was calculated as a percentage of the uninjured side, assuming that the right upper extremity was 10% stronger. No correction was made for left-handed patients.(24) Radiographic evaluation of the results was performed on the 12-month follow-up radiographs. Batra score was calculated and graded into 4 categories of radiographic results: excellent (90–100), good (80–89), fair (70–79), or poor (< 70).(25)

Pain was evaluated both at rest and during activity using the VAS pain score (0 = no pain, 10 = worst imaginable pain).

Data on the duration of time of work and manual labour were collected from patient data records and patient interviews at the 12-month follow-up. Having spent more than 3 months off work was considered as delayed return to work. The type of work was defined as manual or non-manual, based on the Swedish Standard Classification of Occupations (SSYK 2012), which in turn is based on the International Standard Classification of Occupations (ISCO-08).(26, 27)

Statistical analysis

Statistical analyses were performed using version 29.0 of IBM SPSS Statistics for Windows. Demographic data are presented as the number of cases with median and interquartile range (IQR). The Shapiro-Wilk test was used to assess normality of distribution (data not shown). Because the data were not normally distributed and ordinal data were used, the results are presented as median and IQR. Comparisons between groups were made using the Mann-Whitney test, χ² test, and Fisher’s exact test as appropriate.

A univariate logarithmic regression analysis was performed, and parameters with α < 0.1 were considered for inclusion in the multivariate model. Collinearity between parameters was checked before inclusion in the final analysis, using a variance inflation factor of < 5 as a cut-off. Potential parameters were also tested for interaction.

P-values < 0.05 were considered statistically significant.

Baseline characteristics

Of the 84 cases available for this secondary analysis (Fig. 2), 10 had a delayed return to work; 2 in the volar plate group and 8 in the combined plating group. There were no statistically significant differences in baseline data between the treatment groups (Table 2).

Table 2

Baseline characteristics of the treatment groups.
	Volar plating	Combined plating	Total	p-value
Age	53 (47–61)	54 (44–59)	53 (45–60)	NS
Sex, M/F	10/36	10/28	20/64	NS
Side, dx/sin	21/25	18/20	39/45	NS
Fracture subtype, C1/C2/C3	12/19/15	10/17/11	22/36/26	NS
Trauma type, low/high energy	34/12	29/9	63/21	NS
Injury of dominant hand, yes/no	17/29	17/22	33/51	NS
Operating time in minutes	59 (42–74)	85 (71–96)	70 (51–88)	< .001
A χ² test was used for comparison, except for age and operating time, where the Mann-Whitney U-test was used. Age, and operating times is given as median and IQR.

A logistic regression model was used in this study due to the binary outcome (delayed return to work). There were no missing data and no outliers. The univariate analysis was performed for all possible explanatory variables available in the original study; only age had a p-value < .05, but surgical method and manual work had p-values < .10 (Table 3)

Table 3

Univariable logistic regression.
Variable (univariate)	Coefficient (β)	SE	Wald χ²	p-value	Odds ratio	95% CI
Constant	13.289	19.362	.471	.492
Age	0.149	.069	4.640	.031	1.161	1.014–1.329
Sex	-0.783	2.823	.077	.781	.457	.002–115.430
Trauma type	-2.149	1.888	1.295	.255	.117	.003–4.723
Surgical method	2.714	1.476	3.381	.066	15.096	.836–272.536
Operation time	.014	.028	.250	.617	1.014	.960–1.071
Manual labour	4.338	2.407	3.248	.072	76.525	.684–8562.792
Pain at rest	.003	1.004	.000	.997	1.003	.1407.174
Pain during activity	.975	1.042	.876	.349	2.651	.344–20.417
Grip strength	.089	.116	.593	.441	1.093	.871–1.371
Grip strength ratio, injured/uninjured	-5.843	3.949	2.190	.139	.003	.000–6.660
PRWE score	− .119	.112	1.135	.287	.888	.713–1.105
QuickDASH score	.007	.084	.006	.937	1.007	.854–1.186
Batra group	− .691	1.032	.447	.504	.501	.066–3.792
Volar tilt	− .246	.212	1.352	.245	.782	.516–1.184
Radial length	− .018	.659	.001	.979	.983	.270–3.577
Radial angle	.169	.362	.217	.641	1.184	.582–2.408
Bold text indicates p < .05; bold italic text indicates p < .1. CI = confidence interval; PRWE = Patient-Rated Wrist Evaluation; QuickDASH = Quick Disabilities of the Arm, Shoulder, and Hand; SE = standard error.

Age, surgical method, and manual work were included in the multivariate analysis since they had p-values < .10 in univariate analysis, demonstrated low collinearity or interaction, and were regarded as clinically relevant. The only variable that was statistically significantly associated with delayed return to work in the multivariate analysis was combined plating as the surgical method, with an odds ratio (OR) of 7.454 (95% confidence interval [CI]: 1.362–40.804, p = 0.021). The full model is presented in Table 4.

Table 4

Multivariable logistic regression.
Variable (multivariate)	Coefficient (β)	SE	Wald χ²	p-value	Odds ratio	95% CI
Intercept	-8.955	2.848
Operation method	2.009	.867	5.364	.021	7.454	1.362–40.804
Manual work	2.191	1.135	3.725	.054	8.940	.967–82.685
Age	.076	.042	3.234	.072	1.079	.993–1.171

In this secondary analysis, we found that combined plating was associated with a significantly increased risk of delayed return to work following a type C DRF, in comparison to treatment with a volar locking plate. The OR was 7.454 (95% CI: 1.362–40.804), indicating a statistically significant difference in the risk of delayed return to work.

Sick leave is an important contributor to total costs in patients with DRF, and earlier retrospective studies have shown that more invasive treatments are associated with longer sick leave.(4, 28) This is well in line with our results, despite some differences between the study populations regarding AO type. Although it might be assumed that AO type C fractures could benefit from the enhanced stability offered by combined plating, our results suggest otherwise. As the clinical outcomes in the previously published RCT indicated similar radiographic outcomes and inferior clinical outcome parameters, the findings in this present analysis indicate no clinical advantage from using combined plating over volar plating.

The enhanced stability of combined plating fixation does not seem to translate into faster mobilization and rehabilitation, likely because the soft tissue dissections are more extensive and the slight increase in stability is clinically unimportant.(29) Less invasive surgery has also been shown to yield better or similar results as more extensive surgery in several different fractures, such as clavicular, humoral, and tibial fractures.(30–32) Our results on AO type C DRF are in line with these findings.

The original RCT comparing the use of a volar locking plate with the use of combined dorsal and volar plates for surgical treatment of AO type C DRFs demonstrated significantly inferior QuickDASH and PRWE scores in the combined plating group.(16) Neither of these patient-reported outcomes was significantly associated with delayed return to work in this analysis. However, an inferior outcome regarding delayed return to work for the combined plating group is in line with earlier published results.

Pain is known to be the most important factor for outcome after hand surgery.(33) In this study, pain was not associated with an increased risk of delayed return to work. However, increased pain during activity was significantly more common in the combined plating group.

In the present study, we chose to analyse the data in terms of the risk of delayed return to work instead of time off work. The rationale for this is that the Swedish medical insurance guidelines recommend 5–12 weeks of sick leave, depending on the need for rehabilitation and physical demands at work.(34) This means that the majority of surgically treated type C DRF patients return to work at around 12 weeks, most likely due to the social benefits system rather than fracture healing, and so delayed return to work is a more suitable outcome variable than days off work. The results of this study may therefore be most relevant in countries with similar social benefits systems; however, the risk of prolonged recovery is likely higher in combined plating regardless of the social benefits system.

Longer operative time is perceived as a risk factor for post-operative infections, and is associated with an increased risk of complication.(35,36) This potentially increased risk was the reason for an extra dose of antibiotics when operative time exceeded 2 hours.

Except for the comparison between two different surgical methods, no other interventions were implemented to shorten the time off work. In one study of metacarpal and phalangeal fractures, interventions at the workplace shortened the time off work from 56.3 days to 4.8. The effect of these kinds of interventions, regardless of surgical treatment, is an area for further research in DRF.

A limitation of this study is the low number of cases with delayed return to work, which made it difficult to estimate the magnitude of the effects of different parameters and limited the number of parameters that could be included in a multivariate model. Another limitation is the lack of socioeconomic factors other than work. This might have introduced bias, but the RCT design should have limited the effect. The impact of socioeconomic factors could be a topic for future studies, preferably using register data.

Further research in this area could be focused on the impact of other surgical or non-surgical treatment options for DRF. Another area to study would be the effect of hand therapy, or of different interventions in the workplace.

The results of this secondary analysis indicate that combined plating is associated with an increased risk of delayed return to work following a type C DRF when compared to volar plating alone. A restrictive use of combined plating and perhaps of other more invasive surgical techniques is recommended based on these findings.

Ethics approval and consent to participate: The study was approved by the Swedish Ethical Review Authority (ref: 2016-455). All patients gave written informed consent before participation.
Consent for publication: Not applicable.
Availability of data and materials: The datasets used and analysed during the current study are available from the corresponding author upon reasonable request.
Competing interests: The authors declare that they have no competing interests.
Funding: This study was funded by the Research Committee of Region Örebro County.

Authors’ contributions: EN contributed to the methodological design, performed the data analysis, and wrote the original draft. MS contributed to the conceptualisation, project administration, study design, and reviewing and editing the draft. EL contributed to the conceptualisation, study design, and data analysis, and was responsible for data gathering and for reviewing and editing the draft.
Acknowledgements: Not applicable.

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No competing interests reported.

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Delayed return to work after volar or combined plating of type C distal radius fracture: a secondary analysis of a randomised clinical trial

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