Abstract
Aims
The purpose of this study was to assess the effect of combined preoperative benzoyl peroxide application and subcutaneous povidone-iodine (PV-I) disinfection, in addition to standard PV-I disinfection of the skin, on intraoperative cultures of Cutibacterium acnes.
Methods
All patients undergoing arthroscopic or open shoulder surgery were eligible for inclusion. Patients were randomized into one of three groups: control (standard disinfection of the skin with PV-I), double prevention (disinfection of the skin and subcutaneous tissue with PV-I after incision for 60 seconds), and triple prevention (application of benzoyl peroxide during the three days before surgery, disinfection of the skin with PV-I, and disinfection of the subcutaneous tissue with PV-I after incision for 60 seconds). Cultures were taken of the tissue layers, equipment, and the surgeon’s gloves. A sample size of 156 patients was calculated. Culture positivity was compared between the groups, with the intra-articular and deep muscular culture as the primary outcome.
Results
A total of 156 patients (median age 58 years (IQR 20 to 85), with 61 patients (39%) being female) were included. The intra-articular cultures were positive in 16 patients (32%) in the control group, 11 (21%) in the double prevention group, and five (10%) in the triple prevention group (p = 0.031). C. acnes presence in the muscular layer was 21 (42%) in the control group, 17 (33%) in the double prevention group, and seven (13%) in the triple prevention group (p = 0.0052). The median number of positive cultures was one in the control group (IQR 0 to 5), one in the double prevention group (IQR 0 to 3.75), and zero in the triple prevention group (IQR 0 to 2; p = 0.082).
Conclusion
Combining disinfection of the subcutaneous tissue after incision with preoperative application of benzoyl peroxide reduced the presence of C. acnes during surgery. These results suggest that the triple prevention protocol may be effective in reducing C. acnes infections after both arthroscopic and open surgery.
Cite this article: Bone Jt Open 2026;7(2):177–184.
Keywords: Cutibacterium acnes, Benzoyl peroxide, Iodine, Disinfection, Shoulder surgery, Infection, Randomized controlled trial, benzoyl peroxide, shoulder surgery, infections, povidone-iodine, open shoulder surgery, randomized controlled trials, shoulder, Surgical site infections (SSIs), shoulder SSIs
Introduction
Surgical site infections (SSIs) remain a persistent concern after shoulder surgery, particularly in the context of arthroplasty, with reported incidences of periprosthetic shoulder infections as high as 7%.1Cutibacterium acnes is of particular concern due to its commensal nature, indolent behaviour, and its ability to form biofilms.1-3 Although the exact role and pathophysiology of C. acnes in shoulder SSI is not fully understood, C. acnes has been reported to be responsible for up to 44% of shoulder joint infections, with a substantial impact of a positive deep-tissue culture on postoperative outcome.4-6
Considerable efforts have been directed towards the reduction of the bacterial load of C. acnes. The addition of subcutaneous povidone-iodine (PV-I) disinfection to the standard cutaneous disinfection with PV-I has been observed to significantly reduce culture positivity for C. acnes.7 Moreover, several authors reported a significant reduction in C. acnes positivity rates when an additional skin preparation with topic benzoyl peroxide (BPO) was performed several days before surgery or directly before surgery.8-14
While these strategies have demonstrated efficacy in reducing culture positivity, the residual presence of C. acnes indicates the necessity for further optimization of preoperative disinfection.5,15 To our knowledge, there are no previous randomized controlled trials (RCTs) combining multiple preventive strategies against C. acnes. Therefore, the purpose of this study was to evaluate the effect of standard cutaneous PV-I disinfection combined with preoperative BPO application and subcutaneous PV-I infection disinfection (triple prevention) on intraoperative cultures obtained from different surgical sites, skin layers, and the joint space or deep layers. Triple prevention was compared to cutaneous and subcutaneous PV-I (double prevention) and standard cutaneous PV-I (single prevention/control group), the primary hypothesis being that the triple prevention protocol leads to lower culture positivity of the deep layers.
Methods
Design
This study was a prospective, single-blinded, randomized controlled trial, performed at a tertiary referral orthopaedic centre (Alps Surgery Institute, Annecy, France) and conducted according to CONSORT.16 The study was approved by the Institutional Review Board (reference no. 22.03636.00017) and registered with study number NCT05701475 (ClinicalTrials.gov).
Between January 2023 and December 2024, consecutive patients aged over 18 years undergoing all types of surgery at the shoulder joint, acromioclavicular joint, or clavicle, including arthroscopic and open surgery, were prospectively enrolled. Exclusion criteria were previous shoulder surgery, history of shoulder infection, antibiotic treatment within the last six weeks, allergy or hypersensitivity to disinfecting agents, and laboratory values indicative of current infection (elevated CRP, ESR, or leucocyte count). Informed consent was freely given, specific, unambiguous, and revocable at any time. All subjects were legally competent to give consent.
Patients were randomly assigned to one of three groups of equal size: triple prevention group, double prevention group, and single prevention (control) group. Simple block randomization with a 1:1:1 ratio and a block size of 12 was performed. Stratification by open or arthroscopic surgery was employed to ensure an equal number of patients for both types of surgery. Randomization was performed using Study randomizer (Phase Locked Software, Netherlands).17
Patient characteristics
In total, 156 patients were included and randomized to the three prevention arms (Figure 1). The median age in the cohort was 58 years (IQR 20 to 85), 61 patients (39%) were female. A total of 17 patients (11%) were smokers, and six patients (4%) had diabetes (Table I).
Fig. 1.
Flowchart of patient inclusion and randomization.
Table I.
Patient characteristics.
| Variable | Open | Arthroscopic | Control group | Double prevention | Triple prevention |
| Female, n (%) | 36 (46) | 25 (32) | 19 (37) | 17 (33) | 25 (48) |
| Median age, yrs (range) | 57 (20 to 85) | 60 (25 to 84) | 54 (22 to 83) | 60 (20 to 84) | 61 (21 to 85) |
| Median BMI, kg/m2 (range) | 24 (18 to 53) | 25 (19 to 53) | 25 (18 to 53) | 25 (19 to 39) | 24 (19 to 52) |
| Smoking, n (%) | 3 (4) | 13 (18) | 8 (15) | 6 (12) | 3 (6) |
| Comorbidities, n (%) | |||||
| Diabetes | 2 (3) | 4 (5) | 0 (0) | 5 (10) | 1 (2) |
| Hypercholesterolemia | 10 (13) | 15 (19) | 4 (8) | 13 (25) | 8 (15) |
| Hypertension | 10 (13) | 9 (12) | 5 (10) | 8 (15) | 6 (12) |
| Cardiovascular disease | 7 (9) | 9 (12) | 4 (8) | 6 (12) | 6 (12) |
| Pulmonary disease | 4 (5) | 3 (4) | 2 (4) | 2 (4) | 3 (6) |
Treatment protocol
Preoperatively, all three groups were instructed to shower with regular soap the night before and the morning of surgery. Additionally, patients in the triple-prevention group were instructed to apply a 5 cm strip of 5% benzoyl peroxide gel to the shoulder the morning and evening of the two consecutive days before the surgical intervention, repeated a fifth time the morning before surgery, as previously described.11 Standardized preoperative antibiotic prophylaxis was administered 30 to 45 minutes before incision and consisted of intravenous cefazoline 2 g or clindamycin 900 mg in case of penicillin allergy. The upper limb and the shoulder were prepared with 4% PV-I surgical scrub (Betadine scrub 4%; Viatris/MEDA Pharma, Sweden). Skin disinfection was performed with 5% PV-I and ethanol (Betadine alcoolique; Viatris/MEDA Pharma) before draping. In the double-prevention and triple-prevention treatment arms, subcutaneous disinfection was performed immediately after skin incision with 10% PV-I (Betadine dermique 10%; Viatris/MEDA Pharma) for 60 seconds before complete aspiration and lavage.18,19
Outcome assessment
During the intervention, nine bacterial culture swabs (Σ-TRANSWAB MW176S; Medical Wire & Equipment, UK) were taken from the patients’ skin (before disinfection with PV-I), subcutaneous tissue (after disinfection if randomized for subcutaneous disinfection), muscular layer, intra-articular/layer, and instruments (Table II). The applicable fields were swabbed fully for three seconds.
Table II.
Bacterial culture swabs taken intraoperatively for open and arthroscopic shoulder surgery.
| Bacterial culture swab | Open shoulder surgery | Arthroscopic shoulder surgery |
|---|---|---|
| 1 | Skin ipsilateral shoulder (before disinfection with PV-I) | Skin ipsilateral shoulder (before disinfection with PV-I) |
| 2 | Skin contralateral shoulder (before disinfection with PV-I) | Skin contralateral shoulder (before disinfection with PV-I) |
| 3 | Outside scalpel after skin incision | Outside scalpel after skin incision |
| 4 | Subcutaneous tissue (only after disinfection if randomized for one of the subcutaneous disinfection groups, otherwise directly after skin incision) | Subcutaneous tissue (only after disinfection if randomized for one of the subcutaneous disinfection groups, otherwise directly after skin incision) |
| 5 | Muscular/fascial layer | Obturator |
| 6 | Intra-articular (or deepest subfascial layer in case of non-articular surgery) | Intra-articular |
| 7 | Surgeon’s gloves | Arthroscope trocart |
| 8 | Inside scalpel | Switching stick |
| 9 | Retractors | Surgeon’s gloves |
PV-I, povidone-iodine.
The personnel responsible for conducting the laboratory tests were blinded to the treatment arm. Incubation was performed for 14 days under aerobic and anerobic conditions on sheep blood columbia agar and chocolate agar (Thermo Fisher Scientific, USA). Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF) was used to identify C. acnes presence.
The primary outcome was defined as culture positivity for C. acnes of the intra-articular and/or muscular swab. Secondary outcomes included culture positivity for other swab locations, the aggregate number of positive cultures, the presence of any positive culture (cultures number 4 to 9), adherence to the protocol, and the occurrence of adverse effects in the triple prevention group.
Statistical analysis
A sample size calculation was performed with a positive intra-articular culture as the primary outcome using G*Power v. 31 (G*Power, Germany). Based on previous studies,10,11,13 the effect size was set to 0.25, with two degrees of freedom, and the significance level was set to 0.05. A minimum of 155 observations was determined to achieve a power of 0.8. The inclusion target was set at 52 patients in each group, stratified into 26 arthroscopic and 26 open surgery participants. As observations for the primary outcome were recorded during surgery, no loss to follow-up was predicted.
Descriptive statistics were used to report cohort characteristics taking into account the normality of the data distribution. Culture positivity between the groups was analyzed using chi-squared tests and Fisher’s exact test. In case of a significant difference in the primary analysis, subgroup analyses were performed using the same method. Moreover, a two-way analysis of variance (ANOVA) test was performed to compare the total number of positive cultures in case of a normal distribution, and a Kruskal-Wallis test in case of a skewed distribution. To assess the effectiveness of the benzoyl peroxide treatment, the results of the skin culture before preoperative disinfection of Group 3 was compared with Group 1 and 2, including only cases with a positive culture on the contralateral side. Significance level was set at 0.05, and all tests were two-tailed. Statistical analysis was performed using RStudio (Posit, USA) and R v. 4.0.5 (R Foundation for Statistical Computing, Austria).
Results
Cohort
In total, 38 patients (24%) received an intra-articular injection before surgery (Table III). The culture of the contralateral shoulder was positive in 115 patients (77%).
Table III.
Treatment characteristics.
| Variable | Open | Arthroscopic | Control group | Double prevention | Triple prevention |
| Previous injections, n (%) | 7 (9) | 31 (40) | 12 (23) | 12 (23) | 14 (27) |
| Right side operated, n (%) | 33 (42) | 29 (37) | 27 (52) | 15 (29) | 20 (38) |
| Median duration of surgery, mins (IQR) | 54 (25 to 165) | 45 (13 to 109) | 44 (20 to 111) | 53 (17 to 165) | 47 (13 to 149) |
| Type of surgery, n (%) | |||||
| Acromioclavicular reconstruction | 8 (10) | 0 (0) | 4 (8) | 2 (4) | 2 (4) |
| Arthroplasty | 29 (37) | 0 (0) | 8 (15) | 9 (17) | 12 (23) |
| Bankart repair | 2 (3) | 12 (15) | 4 (8) | 6 (12) | 4 (8) |
| Rotator cuff repair | 1 (1) | 48 (62) | 18 (35) | 16 (31) | 15 (29) |
| Fracture | 13 (17) | 0 (0) | 7 (13) | 2 (4) | 4 (8) |
| Latarjet | 21 (27) | 0 (0) | 6 (12) | 8 (15) | 7 (13) |
| Resection of benign tumour or cyst | 2 (3) | 4 (5) | 1 (2) | 4 (8) | 1 (2) |
| Tendon transfer | 2 (3) | 0 (0) | 0 (0) | 1 (2) | 1 (2) |
| Tenodesis | 0 (0) | 14 (18) | 4 (8) | 4 (8) | 6 (12) |
Data quality
In the group that applied benzoyl peroxide, adherence to the protocol was 99.6% (259 of 260 applications performed). Data completeness of the bacterial culture results was 97%.
Primary outcomes
The global comparison of C. acnes culture positivity showed a significant difference between the three groups for both the intra-articular (p = 0.031) and muscular layers (p = 0.0052), with culture positivity rates following a descending trend (Group 1 > Group 2 > Group 3; Table IV).
Table IV.
Outcome assessment.
| Cultures positive for C. acnes | Control | Double prevention | Triple prevention | p-value |
| Total | ||||
| Intra-articular culture, n (%) | 16 (31) | 11 (21) | 5 (10) | 0.0306* |
| Muscular layer culture, n (%) | 21 (42) | 17 (33) | 7 (13) | 0.00526* |
| Any culture positive†, n (%) | 28 (58) | 31 (60) | 20 (44) | 0.263* |
| Median positive cultures†, n (IQR) | 1 (0 to 4.75) | 1 (0 to 3.75) | 0 (0 to 2) | 0.080§ |
| Open surgery | ||||
| Intra-articular culture, n (%) | 11 (42) | 8 (31) | 5 (19) | 0.228* |
| Muscular layer culture, n (%) | 13 (52) | 8 (31) | 4 (15) | 0.0198* |
| Any culture positive†, n (%) | 17 (68) | 17 (65) | 14 (61) | 0.873* |
| Median positive cultures†, n (IQR) | 3 (0 to 6) | 1 (0 to 4) | 1 (0 to 3) | 0.179§ |
| Arthroscopic | ||||
| Intra-articular culture, n (%) | 5 (20) | 3 (11) | 0 (0) | 0.063‡ |
| Muscular layer culture, n (%) | 8 (32) | 9 (35) | 3 (12) | 0.117* |
| Any culture positive†, n (%) | 11 (48) | 14 (54) | 6 (27) | 0.160* |
| Median positive cultures†, n (IQR) | 0 (0 to 2) | 0.5 (0 to 1.25) | 0 (0 to 0.75) | 0.246§ |
Chi-squared test.
Cultures number 4 to 9; excluding cultures of the contralateral side (1), taken before disinfection (2), or of the scalpel (3).
Fisher’s exact test.
Kruskal-Wallis test.
C. acnes, Cutibacterium acnes.
Secondary outcomes
Analysis of cases with a positive contralateral shoulder (n = 115) showed that C. acnes was successfully eradicated in 20 out of 32 cases (63%) in Group 3, compared to 14 out of 78 cases (18%) in Groups 1 and 2 (p < 0.001).
A groupwise comparison of Group 1 with Group 2 and Group 2 with Group 3 showed a significant difference only for the muscular layer culture, with a significantly lower culture positivity in Group 3 compared to Group 2 (p = 0.036). Separate analysis of the arthroscopic and open surgeries reported a significant difference only in the muscular layer of the open surgery group (p = 0.020). The other comparisons of subgroups were not significant (p > 0.063). The number of positive cultures and the number of patients with at least one positive culture did not differ significantly between the groups (p > 0.080). The culture results for each location are reported in Table V. No patients reported side effects after applying BPO.
Table V.
Culture positivity for Cutibacterium acnes for each performed swab.
| Open, n (%) | Arthroscopic, n (%) | |||||
| Swab | Control | Double | Triple | Control | Double | Triple |
| 1 | 17 (68) | 17 (71) | 8 (33) | 19 (83) | 23 (88) | 9 (35) |
| 2 | 21 (84) | 20 (77) | 16 (70) | 19 (76) | 22 (85) | 17 (68) |
| 3 | 11 (44) | 7 (27) | 7 (28) | 3 (12) | 5 (19) | 2 (8) |
| 4 | 11 (44) | 9 (35) | 6 (24) | 4 (15) | 6 (23) | 3 (17) |
| 5 | 13 (52) | 8 (31) | 4 (15) | 3 (13) | 3 (12) | 0 (0) |
| 6 | 11 (42) | 8 (31) | 5 (20) | 5 (20) | 3 (12) | 0 (0) |
| 7 | 13 (52) | 13 (50) | 9 (36) | 9 (36) | 7 (27) | 3 (12) |
| 8 | 14 (56) | 10 (38) | 7 (29) | 8 (32) | 9 (35) | 3 (12) |
| 9 | 14 (56) | 12 (46) | 10 (43) | 4 (18) | 5 (21) | 0 (0) |
Infections
In the overall cohort, two infections (1.28%) occurred, with one infection occurring in each of the Groups 1 and 2. Notably, no infections occurred in Group 3. Both infections occurred following open shoulder surgery, with positive C. acnes cultures from both the muscular layer and intra-articular samples. These cases were managed with surgical lavage and a course of oral antibiotics, resulting in full recovery.
Discussion
This study aimed to compare the effect of preoperative BPO application and subcutaneous PV-I infection on intraoperative cultures of C. acnes with standard preoperative skin preparation in a three-armed single-blinded RCT. A significant difference in C. acnes culture positivity rates between the three groups was reported for both the intra-articular and muscular layers, suggesting that the triple prevention protocol is effective in reducing intraoperative presence of C. acnes in deep tissue layers. The preoperative application of BPO also proved effective, eradicating C. acnes in 63% of cases with a positive contralateral swab.
Although several studies have evaluated the efficacy of preoperative skin preparation with PV-I, only one previous RCT has evaluated the effects of additional subcutaneous disinfection after incision with PV-I.7,20-22 Moor et al7 reported a significantly reduced positive deep layer C. acnes culture rate for additional subcutaneous disinfection with PV-I (relative risk 0.33). Due its effective bactericidal activity at concentrations as low as 0.4%, it may serve as a cost- and time-effective adjunct to reduce C. acnes at the surgical site.22 However, current evidence is limited, and the findings of this study do not permit definitive conclusions regarding the superiority of subcutaneous PV-I over standard protocols.
The preoperative application of BPO proved effective against C. acnes, achieving eradication in 63% of cases with a positive contralateral shoulder and significantly reducing intra-articular positivity. This aligns with previously reported eradication rates of BPO or hydrogen peroxide (HPO) of 67% to 97%.12-14,23,24 In this study, BPO was applied during the three preoperative days, while HPO, the active metabolite of BPO, can also be applied perioperatively when disinfecting the skin. The literature shows considerable heterogeneity in the choice and timing of BPO compared with HPO.10,11,13,23,25 The efficacy of a single HPO disinfection remains inconclusive, with conflicting results reported.9-11,25 Similarly, no difference between single and multiple applications of BPO was reported previously.24 In conclusion, no consensus exists on the optimal agent or timing.
Despite substantial evidence on the effect of BPO or HPO on C. acnes skin positivity rates, few studies have performed intraoperative intra-articular or deep tissue swabs, yielding conflicting results.10,11,13,23,25 While Chalmers et al10 reported a three-fold reduction in intra-articular culture positivity with additional preoperative HPO (10% vs 35%, p = 0.03), Grewal et al25 and Scheer et al11 found no significant difference with additional HPO and BPO, respectively (p > 0.25). These inconsistencies may be attributed to differences in the choice of BPO compared with HPO and application duration, swab sites,11 the inclusion of all cultured bacteria in analysis,10 or absence of statistical analysis of deep swabs.23 In conclusion, no consensus can be reached regarding the effect of BPO or HPO on deep tissue or intra-articular C. acnes presence.
A break-even analysis to assess cost-effectiveness was beyond the scope of this study. However, given the substantial treatment costs associated with shoulder SSIs compared to the relatively low costs of BPO or HPO, multiple cost-effectiveness analyses have demonstrated their substantial economic efficiency.26,27 The reported numbers needed to treat (NNT) range from 1,362 to 4,348, highlighting their cost-saving potential in clinical practice.26,27 Moreover, while the additional cost of PV-I itself is negligible, while the 60 seconds application time of PV-I may cause some additional procedural costs.
This study, along with the majority of research on BPO skin disinfection protocols, does not incorporate long-term follow-up with shoulder SSI as an endpoint, and the sample sizes are likely inadequate for a reliable comparison of SSI rates.10,11,13,23 Consequently, the results of this study have to be interpreted with caution, and implications for clinical practice remain preliminary, pending further research with adequate power and follow-up. As a result, the evidence regarding its effect on SSI rates is limited.15,28 In the setting of shoulder arthroplasty, Mizels et al29 reported a lower short-term revision rate for patients with additional BPO skin preparation in a RCT. However, the difference was not significant and the study was likely underpowered. A further difficulty in diagnosing shoulder SSI with C. acnes is the distinction between true infection and culture positivity or contamination.28,30,31 While culture positivity rates in revision arthroplasty for any reason can reach 50%, infection rates following a positive culture have been reported to range from only 5% to 25%.28,32-34 Thus, the predictive value and the therapeutic consequence of a positive culture remains unclear.28 While some authors have reported the intra-articular presence of C. acnes in healthy shoulders, suggesting its commensal role,31 Torrens et al35 observed a significantly higher complication rate in patients with a positive intra-articular culture following shoulder arthroplasty. The diagnostic challenges of SSI with C. acnes are further emphasized by its indolent nature and the absence of definitive laboratory markers.3,5,15,28 This underscores the need for further research to clarify the clinical implications of C. acnes culture positivity in the absence of symptoms. However, given the cost-effectiveness of the triple prevention protocol and the results of the current study, its implementation into clinical practice may contribute to a reduction in C. acnes SSI rates following shoulder surgery.
Limitations
First, the pre-intervention C. acnes load was estimated by analysis of the contralateral shoulder instead of the treated shoulder before intervention. However, similar bacterial positivity rates have been observed previously for both shoulders.13 Second, given that the sample size calculation was performed for the comparison between the three groups of the primary outcome, the group-wise comparisons and the subgroup analyses regarding open or arthroscopic surgery were underpowered. Third, a long-term follow-up with clinical infections as an endpoint was beyond the scope of this study and underpowered due to the sample size calculation being based on colonization rates. Fourth, the study cohort was heterogeneous in terms of procedure types and patient age, including both arthroscopic and open surgeries. This variability may have introduced additional heterogeneity to the study population. Although clinical infections with C. acnes are less common following arthroscopic procedures compared to open surgery, the inclusion of both approaches reflects real-world clinical practice and enabled exploratory comparisons between the two surgical techniques. While C. acnes is predominantly found in young male patients, this cohort included a more diverse population undergoing shoulder surgery. However, this provides a representative sample of the general population. Fifth, contamination of the swabs cannot be ruled out, however, as all groups were exposed to the same risk, therefore the impact on the results is likely limited. Sixth, multiple preoperative applications of BPO at home may pose challenges for elderly patients. However, adherence to the protocol was high, and the product is generally considered user-friendly. Finally, considering the commensal role of C. acnes and the disputed clinical relevance in shoulder surgery, the culture results cannot be directly extrapolated to infection rates.
In conclusion, in this three-armed, single-blinded, randomized controlled trial, the combination of preoperative application of benzoyl peroxide with subcutaneous disinfection after incision significantly reduced C. acnes positivity rates in the deep layers compared to the standard disinfection protocol and added subcutaneous disinfection alone. The implementation of this strategy into clinical practice may potentially contribute to a reduction in C. acnes surgical site infections following both arthroscopic and open surgery.
Take home message
- Combining disinfection of the subcutaneous tissue after incision with preoperative application of benzoyl peroxide reduced the presence of Cutibacterium acnes during surgery.
- These results suggest that the triple prevention protocol may be effective in reducing C. acnes infections after both arthroscopic and open surgery.
Author contributions
A. A. Macken: Conceptualization, Investigation, Validation, Visualization, Writing – original draft
P. Rab: Conceptualization, Investigation, Validation, Visualization, Writing – original draft
M. N. Soares: Conceptualization, Investigation, Validation, Visualization, Writing – review & editing
D. Boulidam: Conceptualization, Investigation, Validation, Visualization, Writing – review & editing
I. Shirinskiy: Conceptualization, Investigation, Validation, Visualization, Writing – review & editing
G. Macheda: Conceptualization, Formal analysis, Writing – review & editing
S. Bland: Conceptualization, Formal analysis, Writing – review & editing
A. Kling: Conceptualization, Writing – review & editing
T. Lafosse: Conceptualization, Writing – review & editing
G. A. Buijze: Conceptualization, Writing – review & editing
Funding statement
The author(s) disclose receipt of the following financial or material support for the research, authorship, and/or publication of this article: This study was supported by an educational grant from Vivalto Santé (Vivalto Sante Investissement, Paris, France).
ICMJE COI statement
P. Rab received funding grants from Depuy Synthes and Johnson & Johnson for a fellowship. G. A. Buijze receives consulting fees from Stryker Orthopaedics, while T. Lafosse receives consulting fees from DePuy Synthes, Mitek Sports Medicine, Stryker Orthopaedics, Smith & Nephew, and Zimmer Biomet. M. N. Soares received funding grants from the Amsterdam University Medical Centre for international research collaboration.
Data sharing
All data generated or analyzed during this study are included in the published article and/or in the supplementary material.
Ethical review statement
This study was approved by the Comité de protection des personnes Sud-Est III (CPP Sud-Est III) and registered as study number 22.03636.000171.
Open access funding
The open access fee was self-funded.
Trial registration number
ClinicalTrials.gov identifier: NCT05701475
© 2026 Macken et al. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (CC BY-NC-ND 4.0) licence, which permits the copying and redistribution of the work only, and provided the original author and source are credited. See https://creativecommons.org/licenses/by-nc-nd/4.0/
Data Availability
All data generated or analyzed during this study are included in the published article and/or in the supplementary material.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
All data generated or analyzed during this study are included in the published article and/or in the supplementary material.