ORIGINAL ARTICLE |
https://doi.org/10.5005/jojs-10079-1169 |
A Prospective Randomized Study for Comparison of Modified Proximal Femoral Plate with Dynamic Hip Screw System
1–6Department of Orthopedics, Pt BD Sharma, PGIMS, Rohtak, Haryana, India
Corresponding Author: Jitendra Wadhwani, Department of Orthopedics, Pt BD Sharma, PGIMS, Rohtak, Haryana, India, Phone: +919812337494, e-mail: drjitendra28.03@gmail.com
Received: 23 April 2024; Accepted: 29 May 2024; Published on: 14 June 2024
ABSTRACT
Aim: To conduct a prospective randomized study comparing the functional and radiological outcomes of dynamic hip screw (DHS) and modified proximal femoral locking compression plate (PFLCP) in Asian population with intertrochanteric fractures.
Materials and methods: The modified PFLCP design has been created by the authors. The modification to the standard PFLCP design involves increasing the screw density for the trochanteric area, along with the provision of locking as well as compression screw slots. It is an angular stable construct with the ability to achieve compression across the fracture site. We included 112 patients (1:1 parallel design, n = 56) with intertrochanteric fractures. Randomization was done using the lottery method. The mean age was 65.66 years (range, 28–90) and 64.07 years (range, 31–90) in the DHS group and PFLCP group, respectively. The mean duration of surgery, intraoperative blood loss, and functional outcome at 6 months using the Harris hip score (HHS) were compared.
Results: In the DHS group and PFLCP group, the mean time to union was 18.3 and 17.2 weeks, respectively. Significant shortening at final follow-up occurred in 15.68 and 12% of patients (p = 0.59). Postoperative discharge from the surgical site occurred in 5.88 and 4% of patients. Implant failure occurred in 3.92 and 8% of patients (p = 0.43). Varus collapse occurred in 33.33 and 14% of patients (p = 0.022), respectively. The mean HHS was 82.6 and 86.3 in the DHS and PFLCP groups, respectively (p = 0.19).
Conclusion: The modified PFLCP is capable of providing equally effective radiological and functional outcomes. The modified PFLCP can be used as an alternative to the DHS in intertrochanteric fractures in severely osteoporotic patients.
How to cite this article: Wadhwani J, Siwach R, Bansal H, et al. A Prospective Randomized Study for Comparison of Modified Proximal Femoral Plate with Dynamic Hip Screw System. J Orth Joint Surg 2024;6(2):136–141.
Source of support: Nil
Conflict of interest: None
Keywords: Dynamic hip screw, Harris hip score, Intertrochanteric fractures, Modified proximal femoral locking compression plate, Proximal femoral locking compression plate.
INTRODUCTION
Intertrochanteric fractures are a common presentation in old-age patients following a trivial trauma.1,2 Due to the fractures around the hip joint, there is a significant impact on the quality of life and mortality in elderly patients. These fractures are also commonly associated with osteoporosis, which is itself a major health concern worldwide.3
Dynamic hip screw (DHS) has stood the test of time in the fixation of stable intertrochanteric fractures. However, complications such as implant cutouts, shortening, and varus collapse have been reported.4,8 The proximal femoral locking compression plate (PFLCP) uses locking screws for the fixation of the proximal trochanteric region and combi-holes for the fixation of the femoral shaft.9 A locked fixation decreases friction with the periosteum of the underlying bone and tends to promote natural healing. The PFLCP provides angular as well as rotational stability with better pullout strength, functioning as an internalized fixator.10,11
In the literature, there are studies that have shown that the PFLCP is better, comparable, or worse compared to the DHS in terms of outcomes in intertrochanteric fractures.12,16 The PFLCP, although it provides a fixed angular construct, lags behind in providing axial compression across the fracture site, which can be a cause for nonunion in intertrochanteric fractures. Therefore, the authors (RS, JW, HB) modified the PFLCP design in the orthopedic workshop of the institute to overcome these shortcomings by making the following changes.
Modification of PFLCP:
Expanding the proximal part of the plate to accommodate the maximum trochanteric surface area for fixation (Fig. 1).
Increased fixation area by increasing the number of screw holes in the proximal region from the standard three to six.
Providing variable fixation options with three compression screw slots for achieving intraoperative compression across the fracture site and three locking screw slots that will provide angular stability to the construction.
The three proximal locking screw (5 mm) holes are at the following angles to the plate shaft:
First proximal locking hole: 95°.
Second proximal locking hole: 110°.
Third proximal locking hole 125°.
The distal portion of the plate is left with a combi-hole of variable length for fixation of the femoral shaft.
Figs. 1A and B: Front and side view of the modified PFLCP (red arrows denote locking screw holes and black arrows denote compression screw holes) showing the respective trajectory of locking screw in the proximal and distal region of the plate
We have modified the PFLCP to utilize the benefits of an angular stable construct along with the advantage of achieving compression across the fracture site with the help of lag screws through the proximal expanded region of the plate. The plate was made available for use with the help of a local implant vendor. We aimed to conduct a prospective randomized study (Registration number: CTRI/2019/11/022097) to compare the modified PFLCP with the time-tested DHS system for intertrochanteric fractures in terms of functional and radiological outcomes and to observe associated complications in the Asian population.
MATERIALS AND METHODS
This prospective randomized study was conducted from 2019 to 2020 on patients presenting with post-traumatic intertrochanteric fractures to our tertiary-level institute. The procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration. The sample size of 112 patients with an allocation ratio of 1:1 (parallel design) to be included in the study was calculated after power analysis, taking z1−α/2 = 1.96 at a confidence interval of 95% and z1−β = 0.84 at a power of study 80%, and a standard deviation (SD) of 6.51 using a previous study with a difference in mean score (d) of 3.6 with a 10% attrition rate.17 Informed consent was obtained from all the patients included in the study. The study was approved by the Institutional Review Board and Ethics Committee. The functional outcomes using HHSs were considered as primary outcomes, and radiological outcomes were considered as secondary outcomes. Patients were randomized using the lottery method into two groups—patients in one group were treated with the DHS group, and patients in the other group were treated with a modified PFLCP group. The fractures were classified according to the AO/OTA alphanumeric classification.18 Patients with post-traumatic intertrochanteric fracture in adults aged 18 years or older in either sex group were included in the study. Fractures included in the 31A1, 31A2.1, and 31A2.2 AO/OTA classifications were included in the study. Patients with pathological intertrochanteric fractures, open intertrochanteric fractures, previously operated intertrochanteric fractures, and fractures of type 31A2.3 and 31A3 AO/OTA classifications were excluded from the study. The DHS surgery was performed with a standard surgical technique.
For the modified PFLCP surgery, the patient was laid in a supine position on the operating fracture table. A lateral longitudinal incision of about 8–10 cm was made from the tip of the greater trochanter. Standard direct lateral approach dissection of the muscles was performed. After achieving an acceptable reduction of the fracture, the plate was placed across the fracture site. A guide wire (2.5 mm) was passed through the proximal locking hole of the plate with the help of a locking sleeve. A de-rotation wire (2.5 mm) was passed through another proximal locking hole using a locking sleeve. The position of wires and the fracture reduction was confirmed in anteroposterior and lateral views under fluoroscopy. Then, a compression screw (6.5 mm) was passed through the compression plate hole across the fracture site. One or two more compression screws (6.5 mm) were passed as needed. Two proximal locking screws (5 mm) were fixed in the proximal femoral region. One distal cortical screw (4.5 mm) closest to the fracture site was passed to align the plate with the bone, followed by 2–4 distal cortical screws (4.5 mm) or locking screws (5 mm) depending upon the strength of the bone. After a thorough wash, wound closure was performed in layers.
All the surgeries were performed by authors (RS, JW) as senior surgeons. Postoperatively, static quadriceps exercises were started the next day. Sutures were removed 2 weeks after the surgery, and straight leg raising and heel slide exercises were initiated. Initially, patients were advised to walk with the help of a walker using a three-point gait, and later, based on the patient’s compliance, a two-point gait was advised 4 weeks after the surgery. The minimum follow-up duration was 6 months. At each follow-up at 1, 3, and 6 months postoperatively, anteroposterior and lateral radiographs were obtained. All these radiographs were assessed by authors (HB, PK) with an interobserver agreement of κ 0.81. Union was considered if there were bridging trabeculae across the fracture site in at least three out of four cortices in anteroposterior and lateral views. Significant shortening was defined as a condition with limb length discrepancy of >2 cm.12 The neck-shaft angle (NSA) was measured in the immediate postoperative radiograph and at 6-month follow-up (Figs 2A and B). Significant varus collapse was considered if the difference between the NSA in radiographs at postoperative and at 6-month follow-up was >10°.19 Functional assessment of patients was done with the help of the HHS at 6 months, postoperatively.
Figs. 2A and B: (A) Immediate postoperative anteroposterior radiograph of pelvis with both hips showing fixation of intertrochanteric fracture with modified PFLCP and NSA of 133.48°; (B) Anteroposterior radiograph of pelvis with both hips showing NSA at 6 months follow-up of 132.97° and no varus collapse
RESULTS
The Consolidated Standards of Reporting Trials (CONSORT) flowchart is provided in Figure 3. Table 1 depicts the various demographic parameters and classification of the groups. A total of 112 patients were part of the study cohort, and three patients in each group were lost to follow-up. Two patients from the DHS group and three patients from the PFLCP group died before the final follow-up of the study. Delayed union was present in four (8.3%) patients of the DHS group and three (6.5%) patients of the PFLCP group. Seven patients (6.93%) of the study cohort (DHS group = 3, PFLCP group = 4) had nonunion at the fracture site, with the difference being statistically insignificant (p = 0.71, Chi-squared test). Table 2 depicts the comparison of various parameters among the two groups. The respective complications of both groups are depicted in Table 3.
| Parameter | DHS group | PFLCP group | p-value |
|---|---|---|---|
| Mean age (years) | 65.66 ± 12.04 | 64.07 ± 13.84 | 0.51 (unpaired student’s t-test) |
| Range | 28–90 | 31–90 | |
| Sex | 0.55 (Chi-squared test) | ||
| Male | 20 (35.71%) | 23 (41.07%) | |
| Female | 36 (64.28%) | 33 (58.92%) | |
| Mechanism of injury | 0.80 (Chi-squared test) | ||
| Slip and fall | 40 (71.42%) | 43 (76.78%) | |
| RTA | 9 (16.07%) | 7 (12.50%) | |
| Fall from height | 7 (12.50%) | 6 (10.71%) | |
| AO classification | 0.91 (Chi-squared test) | ||
| 31A1.1 | 11 (19.64%) | 10 (17.85%) | |
| 31A1.2 | 10 (17.85%) | 9 (16.07%) | |
| 31A1.3 | 9 (16.07%) | 6 (10.71%) | |
| 31A2.1 | 9 (16.07%) | 13 (23.21%) | |
| 31A2.2 | 8 (14.28%) | 8 (14.28%) | |
| 31A2.3 | 9 (16.07%) | 10 (17.85%) |
| Parameter | DHS group | PFLCP group | p-value |
|---|---|---|---|
| Mean duration of surgery (minutes) | 74.29 ± 11.96 | 77.32 ± 13.03 | 0.20 (unpaired student’s t-test) |
| Mean intraoperative blood loss (mL) | 303.21 ± 81.88 | 319.46 ± 80.19 | 0.29 (unpaired student’s t-test) |
| Requirement of blood transfusion | 8 (14.28%) | 9 (16.07%) | 0.79 (Chi-squared test) |
| Mean duration of hospital stay (days) | 5.64 ± 3.39 | 6.00 ± 4.16 | 0.62 (unpaired student’s t-test) |
| Functional outcome | |||
| Mean HHS | 82.6 ± 27.07 | 86.3 ± 30.40 | 0.19 (unpaired student’s t-test) |
| Excellent | 26 (50.98%) | 31 (62%) | 0.41 (Chi-squared test) |
| Good | 11 (21.56%) | 10 (20%) | |
| Fair | 11 (21.56%) | 5 (10%) | |
| Poor | 3 (5.88%) | 4 (8%) | |
| Mean time to radiological union (weeks) | 18.38 ± 3.70 | 17.26 ± 3.43 | 0.13 (unpaired student’s t-test) |
| Complication | DHS group | PFLCP group | p-value |
|---|---|---|---|
| Postoperative discharge | 3 (5.88%) | 2 (4%) | 1.00 (Fisher’s exact test) |
| Implant failure (screw cutout) | 2 (3.92%) | 4 (8%) | 0.43 (Fisher’s exact test) |
| Varus collapse | 17 (33.33%) | 7 (14%) | 0.022 (Chi-squared test) |
| Muscle wasting | 7 (13.72%) | 6 (12%) | 0.79 (Chi-squared test) |
| Significant shortening | 8 (15.68%) | 6 (12%) | 0.59 (Chi-squared test) |
| Requirement of revision surgery | 3 (5.88%) | 4 (8%) | 0.71 (Fisher’s exact test) |
Fig. 3: Consolidated Standards of Reporting Trials flow diagram
DISCUSSION
The DHS works on the principle of controlled collapse. Varus collapse is a complication of the above principle, causing uncontrolled shortening and medialization of the shaft, especially in unstable intertrochanteric fractures.13 PFLCP, being a locking plate system, delivers forces through the screw head to the plate and not at the bone-plate interface, preserving the blood supply of the bone underneath the plate. The locking screw mechanism provides rigid fixation and prevents loosening and varus collapse. Thus, PFLCP merges locking screw technology with conventional plating techniques, providing three-dimensional angular stable fixation.13,20 The modified PFLCP, in addition to the above principles, also provides multidirectional nonlocking cancellous screw slots, which achieve compression across the fracture site and form a triangular fixation frame in the proximal fragment. Along with the larger holding force of lag screws, this further prevents collapse and medialization of the shaft. Modified PFLCP also provides for lateral wall buttress, which prevents lateralization of the proximal fragment, a feature not possible with the use of DHS (Figs 4A and B).
Figs. 4A and B: (A) Preoperative anteroposterior radiograph of pelvis with both hips showing intertrochanteric fracture; (B) Anteroposterior radiograph of proximal thigh at 6 months follow-up showing fixation with modified PFLCP
Mean HHS at 6-month follow-up was higher in the PFLCP group than the DHS group (Table 2) but not statistically significant. The HHS in the DHS group is comparable to the study by Singh et al., which had a score of 81.7, while it is higher in the PFLCP group in our study compared to other studies by Singh et al. and Zang et al., which had scores of 76.1 and 72.6, respectively. This difference might be possible due to the modification done in the PFLCP, which includes an increased fixation area with an increased number of screw holes from the standard three to six and variable fixation options.5,20 In the DHS group, good to excellent results were obtained in 37 patients (72.54%) in our study which is comparable to Seetharamaiah et al. with 21 patients (69.99%) and Asif et al. with 21 patients (60%).13,21 In the PFLCP group, good to excellent results were obtained in 41 patients (82%) in our study which is also comparable to Seetharamaiah et al. with 24 patients (80%), Das et al. with 23 patients (88.45%), Agrawal et al. with 23 patients (88.45%) and Asif et al. with 24 patients (88.%).12,13,21,22 However, the results were not significantly different in terms of functional outcome (p = 0.41, Chi-squared test), it can be derived from our study that good to excellent results were more attainable with modified PFLCP (41 patients, 82.00%) compared to DHS (37 patients, 72.54%) because of the better fixation construct formation after application of modified PFLCP.
Significant shortening was observed in eight (15.68%) and six (12%) patients in the DHS group and PFLCP group, respectively with p = 0.59 (Chi-squared test). Seetharamaiah et al. observed limb shortening in seven (23%) patients of the DHS group and three (10%) patients of the PFLCP group, similar to our study.13 Collapse at the fracture site which is due to the inherent principle of DHS can be responsible for limb shortening. Comminution at the fracture site, unstable fracture pattern, inaccurate fracture reduction, loosening of the implant, and osteoporosis are the risk factors for varus collapse and future limb shortening.23 While modified PFLCP is an angular stable construct, owing to the locking screws, has a lower risk of varus collapse and limb shortening.
Revision surgery was required in seven patients (6.93%), out of which six were required secondary to implant failure in both groups (DHS group = two patients, PFLCP group = four patients), and one patient in the DHS group had a primary nonunion. The difference between the two groups was statistically insignificant (p = 0.71, Fisher’s exact test). We analyzed the results of these failed implant cases according to the intention-to-treat analysis, and the outcomes of these patients were analyzed before the revision surgery only. The revision surgery performed was valgus osteotomy using a 120° angled blade plate in two patients of each group. In one patient of the PFLCP Group, modular bipolar hemiarthroplasty with trochanteric wiring was done. Total hip arthroplasty with trochanteric wiring was performed in one patient of the PFLCP group. In our study, three patients (5.88%) in the DHS group had nonunion, and four patients (8.00%) in the PFLCP group had nonunion; the difference between the two was statistically insignificant (p = 0.71, Fisher’s exact test). Agrawal et al. also had more patients with nonunion in the PFLCP group (one patient, 3.84%) compared to the DHS group (none of the patients).12 In the study by Zang et al., nonunion was seen in one patient (2%) in each of the DHS group and PFLCP group.20 Two patients (3.92%) of the DHS group and four patients (8%) of the PFLCP group had implant failure, the difference between the two was statistically insignificant (p = 0.43, Fisher’s exact test). Other studies by Asif et al., Agrawal et al., and Seetharamaiah et al. had implant failure in three patients (8.57%), none of the patients and two patients (6.66%), respectively in the PFLCP group and in three patients (11.11%), one patient (3.84%) and four patients (13.33%) respectively in DHS group, which are comparable to our study.12,12,21
There was a statistically significant difference (p = 0.022, Chi-squared test) between the two groups in terms of varus collapse. Similarly, varus collapse was also more common in the DHS group compared to the PFLCP group in other studies by Asif et al. (DHS group = 22.85%; PFLCP group = 8.57%), Agrawal et al. (DHS group = 3.84%; PFLCP group = 0%), Dhamangaonkar et al. (DHS group = 25%; PFLCP group = 10%), and Seetharamaiah et al. (DHS group = 23.33%; PFLCP group = 10%).12,13,21,23 This can be attributed to the locking mechanism of the PFLCP which prevents varus collapse at the fracture site and provides multiaxial stability.
Our study has some limitations. As it is an initial investigation, further research using a larger sample size for better assessment is recommended. The length of follow-up was relatively short (6 months), and a longer duration is recommended to provide a more comprehensive evaluation of functional outcomes. The surgeons were new to the operative techniques and principles of the modified PFLCP, which could introduce a technical bias favoring DHS. The comparison was made only with an extramedullary fixation device (DHS) and not with any intramedullary fixation devices like the proximal femoral nail. Additionally, only fractures with lesser comminution (31A1, 31A2.1, and 31A2.2 AO/OTA classification) were studied for comparison with DHS, as it is not recommended in comminuted intertrochanteric fractures.
Prospective randomized study design and statistically proven results are strengths of our study. This is the first study in English literature about this type of innovation in implant design for a very common fracture in orthopedic practice. We have found that modified PFLCP is capable of providing comparable results to DHS with the advantage of having fewer complications, especially varus collapse, and equivalent functional outcomes. DHS is an age-old implant that has yielded good results and has stood the test of time. The impact of DHS in the management of intertrochanteric fractures cannot be denied, and this implant is likely to remain in the armamentarium of trauma surgeons for a long time. Modified PFLCP can be a better choice in severely osteoporotic patients with intertrochanteric fractures. We recommend more prospective randomized controlled studies with larger sample sizes and longer follow-ups for the use of this innovative modified PFLCP implant design.
CONCLUSION
The outcomes of the modified PFLCP are comparable to that of DHS in the internal fixation of intertrochanteric fractures. Modified PFLCP can be used as an alternative to DHS in intertrochanteric fractures in severely osteoporotic patients.
Clinical Significance
Modified PFLCP represents a completely new implant design for intertrochanteric fractures. The angular stability as well as compression across the fracture site are the key advantages, especially in osteoporotic fractures. It prevents the progressive varus collapse due to locking screws across the intertrochanteric fracture, which is a drawback of the DHS system.
ORCID
Jitendra Wadhwani https://orcid.org/0000-0002-3656-3281
Ramchander Siwach https://orcid.org/0009-0008-7162-3877
Himanshu Bansal https://orcid.org/0000-0002-4441-4737
Roop Singh https://orcid.org/0000-0002-5996-5099
Pradeep Kamboj https://orcid.org/0000-0002-6526-9823
Hemant More https://orcid.org/0000-0001-9704-1148
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