Asymptomatic implant removal after fracture union based on request to remove. Is it worth considering, an Indian perspective?

INTRODUCTION

The surgical removal of orthopedic hardware or implants used for the fracture fixation of bones is considered as one of the most commonly performed orthopedic surgeries.^[1] In a study conducted in Germany in 2010, a total of 1,80,000 hardware removals were performed, making this type of surgery the fourth-most common surgical procedure in the orthopedic field.^[2]

However, there is still a debate in the literature regarding the justification of elective surgical implant removal.^[3,4] The common indications for removal are surgical site infection, loosening of implant, metal allergy, implant failure, soft tissue compromise and union failure; the minor indications include intended improvement of function, regional pain, foreign body sensation, implant irritation and MRI compatible issues. However, the above mentioned literature does not offer any instances of implant removal based on patients’ desire because “implants are simply not required once fracture has fully united”.

In a 2008 study by Hanson, which included 730 patients in Davos, Switzerland, 380 of 655 surgeons (58%) disagreed that routine implant removal was unnecessary while 48% felt that removal was riskier than leaving an implant in situ. These findings were probably influenced by various unwanted complications that could occur during and after implant removal.^[5–9] The socioeconomic impact of implant removal must therefore also be taken into consideration, especially in a developing country like India, where less only than 20% of the total population has access to medical insurance. In fact, hardware removal is cost- and time-consuming for both patients and hospitals, and any complication would further increase the financial burden on patients, leading to emotional breakdown and feelings of disheartenment.

Our study aimed to evaluate the risk, benefit and drawbacks of asymptomatic implant removal based solely on patients’ request, using a simple, easily comprehensible and self-explanatory questionnaire. We hypothesized that our patients’ satisfaction after implant removal would be high when their requests for removal had been taken into consideration since patients tend to avoid keeping a metal throughout life if doing so is not required, despite the possibility of associated post-surgery complications.

MATERIAL AND METHODS

Our study was conducted in two hospitals by the same team of surgeons between February 2018 and August 2022. Overall, 105 consecutive patients aged between 10 and 65 years (mean age of 37 years) were included in the study. Patients with occasional pain at the site of implant, especially in winter due to unknown reasons, were also included. In summary, this study included 39 women, 56 men and 10 children (aged between 10 and 15 years). All of the patients’ fractures were united radiographically and were deemed clinically asymptomatic. Notably, the study was conducted only after the approval of a relevant institutional review board, and all patients signed an informed consent form agreeing to participate in the same.

First, all patients were carefully examined to rule out any clinical indications for removal. Accordingly, patients who had previously undergone hardware removal for a known cause – such as infection, implant irritation, implant failure, painful implant and fracture non-union – were excluded from the study. The study aimed to evaluate the patients’ satisfaction levels after asymptomatic implant removal on patients’ request, that is, the request for implant removal by asymptomatic patients.

At 6 months after removal, a patient satisfaction questionnaire was prepared for all the patients of our cohort. It consisted of two questions: (1) Are you happy and satisfied that the hardware was removed and (2) What are your overall experiences after surgery?

Moreover, the Short Musculoskeletal Function Assessment Questionnaire (SMFA) and the Medical Outcomes Study (MOS) Short Form-36 (SF-36), two standardized surveys assessing functional outcomes, were recorded as a baseline at 3, 6 and 12 months after removal (to obtain post-operative data). In addition, SF-36 health survey score questionnaires were used both preoperatively and post-operatively, and as per the scores recorded, many patients were deemed satisfied and asymptomatic. Furthermore, information was obtained from each patient (interview, pain score, SF-36, SMFA) from their respective hospital chart (injury and treatment information) and their post-operative radiographs (healing of the fracture, type of plate and screws, and prominence of the hardware) for our study. To determine each patient’s satisfaction level, she or he was interviewed by one of the authors.

RESULTS

For the 105 patients surveyed, implant removals were performed in the leg (41 patients; 39%), ankle joint (32 patients; 30%), thigh (19 patients; 18%) and forearm and the wrist (15 patients; 14%). Out of the total number of patients, 10 were children in the 10- to 15-year age group. Among them, six had fractured shaft femur and were treated by plating, while the remaining four were treated for fractured radius and ulna. The hardware of all 10 children (9% of the entire cohort) were removed within 1 year since index surgery, as desired by their parents. Notably, the most common indication for hardware removal was patients’ request (66 patients; 62.8%), while surgeon recommendation – in cases of previous surgery– was the indication for 23 patients (21.9%). Moreover, MRI compatibility issues served as the indication for 5 patients (4%), while 11 patients (10.4%) thought that their pain occurred due to their implant.

The demographic characteristics of the entire study population are shown in Table 1. Out of the entire cohort, 98 (93%) patients were satisfied irrespective of the nature of the specific implant removed. All of the 10 children (9.5%) in the cohort underwent removal operations within one year since their index surgery [Table 2]. In addition, the types of implants and the different anatomical sites are shown in Table 3. Interestingly, we noted various peri- and post-operative complications in 35 (32.8%) patients.

Furthermore, the localisations of surgical hardware removal from body parts are shown in Figure 1. As per Figure 2, delayed wound healing was the most common complication in 31% of the cohort, followed by infections. To reiterate, patients’ request was the most common reason for surgical removal of implant [Figure 3].

Close

Figure 1:

Localisations of surgical hardware removal.

Export to PPT

Close

Figure 2:

Post-operative complications following removal of asymptomatic orthopedic implants.

Export to PPT

Close

Figure 3:

Indications of implant removal.

Export to PPT

As mentioned above, the most common indication for hardware removal in our study was patients’ desire – in 66 (62.8%) cases – while surgeon recommendation (in cases of previous surgery) was the indication in 23 (21.9%) cases. MRI compatibility issues served as the indication in five (04%) cases, while 11 patients (10.4%) thought that their occasional pain was due to their implants.

Of the cohort, 69% exhibited high satisfaction levels upon the fulfilment of their desire, reporting significant subjective improvements in overall function after implant removal. In this vein, the scores of the SF-36 are shown in Figure 4, with higher scores indicating higher functional levels. Notably, the mean SF-36 scores for patients with implant-related pain (n = 11) were significantly lower in all the sub-score areas. The greatest of such difference was observed regarding pain where a given implant was located; in this regard, patients who thought that their hardware induced pain had a mean score of 42.6 ± 31.4, whereas pain-free patients who still desired hardware removal had a mean score of 71.3 ± 28.5 (p = 0.0006). The average scores regarding emotional status were 31.82 ± 19.20 for patients with pain and 26.76 ± 16.3 for patients without pain (p = 0.001). Table 4 contains the SMFA scores for the dysfunction and bother indices at pre-surgery (baseline) and after implant removal.

Close

Figure 4:

Selected SMFA sub-scores for patients with and without a hardware-related problem. Lower the scores better the function. Statistical significance was reached for each sub-score presented (p < 0.006 for all).

Export to PPT

DISCUSSION

In our study, the patients had a positive experience insofar as their requests for orthopedic implant removal were considered. Of the total cohort who underwent orthopedic implant removal, 65% reported high satisfaction levels, despite minor complications being reported, for example, impaired wound healing occurring during or after the procedure. The patients clearly articulated that they were happy and satisfied, especially because many surgeons had previously refused to consider their request for implant removal in the absence of clinical indications.

LIMITATIONS

This study focused on patient experience and satisfaction with respect to a particular surgical intervention based on their desires. Data collection was also limited to verbal focus-group interviews with a small cohort of patients. Thus, it inherently offers limited transferability. Therefore, future research should investigate patients’ experiences in a variety of contributory roles across different surgical fields in order to draw stronger conclusions. Clearly, the establishment of definite correlations between psychological factors, patient satisfaction and clinical improvement warrants further investigations.

CONCLUSION

In our study, we noted a high rate of satisfied patients after surgical hardware removal despite the explained and noticed complications. Hence, we suggest that implants should only be removed in light of clinical indications and not merely be based on patient requests. Although the concomitant complication risk is considered to be only as high as 32.8%, keeping in mind patients’ safety and quality of life, any indication for asymptomatic implant removal still has to be assessed and scrutinized judiciously.

In summary, patient requests cannot be considered as the absolute indication for implant removal. Nevertheless, the removal of implant gives patients a high level of satisfaction. In our study, the majority of patients considered the futility of keeping a metal in their bodies throughout their lives even when it was not required, despite the surgeon’s opinion that it would not be necessary to remove their implants even after the fracture union.