Core decompression combined with platelet-rich plasma-augmented bone grafting for femur head necrosis: a systematic review and meta-analysis

Background: The clinical potential of biologic augmentation in core decompression and bone grafting for femoral head necrosis is widely acknowledged, with platelet-rich plasma (PRP) being a frequently employed biologic adjunct. However, its clinical application is not standardized, and high-level evidence is lacking. This study aimed to evaluate the efficacy and safety of core decompression and bone grafting combined with PRP for femur head necrosis. Methods: Several databases were systematically retrieved for randomized controlled trials comparing core decompression and bone grafting combined with or without PRP. A systematic review and meta-analysis were conducted following the PRISMA 2020 and AMSTAR 2 guidelines. The study is registered with PROSPERO under the code CRD42022361007, and it is also listed in the research registry under the identification number reviewregistry1537. Results: Eleven studies with 642 participants (742 hips) were included. The pooled estimates revealed that when core decompression and bone grafting were combined with PRP, the Harris hip score (mean difference: 7.98; 95% CI: 5.77–10.20; P<0.001), visual analog scale (SMD: −0.68; 95% CI: −0.96 – −0.40; P<0.001) and the pain component of Harris hip score (SMD: 8.4; 95% CI: 4.12–12.68; P<0.001), and reduction of radiographic progression [risk ratio (RR): 0.40; 95% CI: 0.27–0.59; P<0.001] were superior to core decompression and bone grafting alone. Fewer patients with treatment failure (RR: 0.27; 95% CI: 0.14–0.52; P<0.001) and higher good-to-excellent results (RR: 1.48; 95% CI: 1.17–1.86; P<0.001) were observed in treatment groups than control groups. Meanwhile, the pooled analysis substantiated the superior safety profile of PRP (RR: 0.29; 95% CI: 0.11–0.77; P=0.01). Conclusions: The combination of core decompression and bone grafting with PRP is superior to the approach without PRP, demonstrating enhanced effectiveness in terms of function, pain relief, and radiographic progression. Additionally, it results in lower rates of treatment failure and adverse events. However, further high-quality RCTs are needed to evaluate their effectiveness due to methodological and implementation limitations observed in the existing evidence.


# Checklist item
Location where item is reported RESULTS

Study selection
16a Describe the results of the search and selection process, from the number of records identified in the search to the number of studies included in the review, ideally using a flow diagram.
P4-P5, P19 16b Cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded.P19

Study characteristics
17 Cite each included study and present its characteristics.P5, P20-P22 Risk of bias in studies 18 Present assessments of risk of bias for each included study.P5-P6

Results of individual studies
19 For all outcomes, present, for each study: (a) summary statistics for each group (where appropriate) and (b) an effect estimate and its precision (e.g.confidence/credible interval), ideally using structured tables or plots.

P6-P8
Results of syntheses 20a For each synthesis, briefly summarise the characteristics and risk of bias among contributing studies.P6-P8 20b Present results of all statistical syntheses conducted.If meta-analysis was done, present for each the summary estimate and its precision (e.g.confidence/credible interval) and measures of statistical heterogeneity.If comparing groups, describe the direction of the effect.

P6-P8
20c Present results of all investigations of possible causes of heterogeneity among study results.P6-P8 20d Present results of all sensitivity analyses conducted to assess the robustness of the synthesized results.

P6-P8
Reporting biases 21 Present assessments of risk of bias due to missing results (arising from reporting biases) for each synthesis assessed.P6-P8

Certainty of evidence
22 Present assessments of certainty (or confidence) in the body of evidence for each outcome assessed.P8

Did the review authors perform study selection in duplicate?
For Yes, either ONE of the following:  at least two reviewers independently agreed on selection of eligible studies and achieved consensus on which studies to include  OR two reviewers selected a sample of eligible studies and achieved good agreement (at least 80 percent), with the remainder selected by one reviewer.
AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or nonrandomised studies of healthcare interventions, or both

Did the review authors perform data extraction in duplicate?
For Yes, either ONE of the following:  at least two reviewers achieved consensus on which data to extract from included studies  OR two reviewers extracted data from a sample of eligible studies and achieved good agreement (at least 80 percent), with the remainder extracted by one reviewer. Must have reported on the sources of funding for individual studies included in the review.Note: Reporting that the reviewers looked for this information but it was not reported by study authors also qualifies AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or nonrandomised studies of healthcare interventions, or both For Yes:  There was no significant heterogeneity in the results  OR if heterogeneity was present the authors performed an investigation of sources of any heterogeneity in the results and discussed the impact of this on the results of the review

If they performed quantitative synthesis did the review authors carry out an adequate investigation of publication bias (small study bias) and discuss its likely impact on the results of the review?
For Yes:  performed graphical or statistical tests for publication bias and discussed the likelihood and magnitude of impact of publication bias AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or nonrandomised studies of healthcare interventions, or both

Did the review authors report any potential sources of conflict of interest, including any funding they received for conducting the review?
For Yes:  The authors reported no competing interests OR  The authors described their funding sources and how they managed potential conflicts of interest The main controversy between the two reviewers centered on an article "Therapeutic effect of ceramic bone compression and bone grafting combined with platelet rich plasma on early femoral head necrosis "( excluded article, DOI:10.3969/j.issn.1672-3511.2020.12.013), which is similar in data with the previously published article "Evaluation of short-term efficacy of autologous plateletrich plasma combined with ceramic bone grafting in the treatment of early femoral head necrosis "( included article, DOI:10.16548/j.2095-3720.2019.04.005), and there was a suspicion of duplicate publication.After verification, we confirmed that there was data reuse in this article by contacting the author, and this article was excluded subsequently.

Appendix 4
The description of postoperative management was not specific enough and varied greatly (especially load limit), and the quality of implementation is difficult to determine.Therefore, it's hard to classify and discuss.

1. Did the research questions and inclusion criteria for the review include the components of PICO?
27 Report which of the following are publicly available and where they can be found: template data collection forms; data extracted from included studies; data used for all analyses; analytic code; any other materials used in the review.P12 From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al.The PRISMA 2020 statement: an updated guideline for reporting systematic reviews.BMJ 2021;372:n71.doi:10.1136/bmj.n71Formore information, visit: http://www.prisma-statement.org/

. Did the review authors explain their selection of the study designs for inclusion in the review
?For Yes, the review should satisfy ONE of the following: Explanation for including only RCTs  OR Explanation for including only NRSI  OR Explanation for including both RCTs and NRSI  Yes  No 4. Did the review authors use a comprehensive literature search strategy?For Partial Yes (all the following):

If meta-analysis was performed, did the review authors assess the potential impact of RoB in individual studies on the results of the meta-analysis or other evidence synthesis
?For Yes: included only low risk of bias RCTs  OR, if the pooled estimate was based on RCTs and/or NRSI at variable RoB, the authors performed analyses to investigate possible impact of RoB on summary estimates of effect.

. Did the review authors provide a satisfactory explanation for, and discussion of, any heterogeneity observed in the results of the review?
The number of included and excluded articles after reading the full text b. Using the asymptotic standard error assuming the null hypothesis.

Table R
1 studies with some bias in random sequence generation, allocation concealment and blinding of participants and personnelQuality

assessment No of patients Effect Quality Importance No of studies Design Risk of bias Inconsistency Indirectness Imprecision Other considerations Good-to- excellent results Control Relative (95% CI) Absolute Good-to-excellent results
studies with some bias in random sequence generation, allocation concealment and blinding of participants and personnel 2 Total sample size, categorical variables < 300 cases 1