Abstract
Background
Several articles have been published reporting on the clinical performance of a novel pegged, all-polyethylene glenoid component design which features a central peg, circumferentially fluted, interference-fit peg for tissue integration and three small peripheral pegs for cementing. However, no systematic review exists to this date.
Methods
The US National Library of Medicine (PubMed/MEDLINE), EMBASE, and the Cochrane Database of Systematic Reviews were queried for publications up to May 2020.
Results
Overall, 13 articles were included for analysis (560 operated shoulders, range of mean follow-up: 2–6 years). The survival rate was 98.2% (550 out of 560 cases), while the rate of aseptic loosening was 0.2% (1 out of 560 cases). There were 139 cases (out of 399 reported; 34.1%) with peri-glenoid radiolucency, and 35 cases (out of 223 reported; 15.7%) of asymptomatic central peg osteolysis, with 1 of them undergoing revision.
Conclusions
There was fair quality of evidence to show that partially cemented all-polyethylene pegged bone-ingrowth glenoid components produce promising results, with a low revision rate in the short- to medium-term follow-up. Nevertheless, this analysis showed high rates of both radiolucency of the glenoid component and osteolysis around the central peg which raise concern for potential failure of this glenoid component in the long-term follow-up.
Level of evidence
Systematic review, IV.
Keywords
Introduction
The anatomic total shoulder arthroplasty (TSA) may be considered as the definite treatment of osteoarthritis of the glenohumeral joint with an intact rotator cuff, not only addressing the pain but also restoring the functionality of the limb. 1 Despite the satisfactory mid-term results reported with the use of all-cemented glenoid components, 2 glenoid component loosening and failure remain the most common long-term complications of TSA.3,4 Radiolucency around the glenoid component, which has been correlated with loosening and failure of the prosthesis after TSA,5,6 has been reported to be as high as 15% at two-year follow-up, and 79% at seven-year follow-up using conventional pegged cemented glenoid components.7,8 Although little is known about the cause of this loosening, some studies report failure in the cement-bone interface, 9 suggesting that cemented-induced thermal necrosis may contribute to osteocyte death and ultimately to the appearance of radiolucent lines. 10 In contrast, retrieval studies have indicated that failure occurs partially 9 or totally 11 in the implant–cement interface.
Unfortunately, cementless metal-back glenoid component studies reveal osteolysis, clinical loosening, and higher component failure rates compared to cemented glenoid implants in the long-term follow-up. 12 Specifically, Gauci et al. found that the survival of a cemented polyethylene glenoid component is three times higher than that of a cementless metal-backed glenoid component 10 years after a TSA in patients with primary glenohumeral osteoarthritis. 13 Furthermore, an analysis obtained from the Australian Orthopaedic Association National Joint Replacement Registry showed that patients undergoing primary TSA procedures with cemented glenoid components had a much lower revision rate than those with cementless: 3.7% versus 17.9% (hazard ratio for entire period, 4.77). 14
In an attempt to decrease cement utilization while avoiding problems associated with metal-backed glenoid components, a novel pegged, all-polyethylene glenoid component design was developed which features a circumferentially fluted, central, cementless, interference-fit peg for tissue integration and three small cemented peripheral pegs. 15 Wirth et al. reported their results using this cementless fluted pegged glenoid component in a canine model which showed excellent biomechanical stability and bony ingrowth around the peg flanges. 15 A number of articles have been published reporting on the clinical performance of partially cemented all-polyethylene pegged bone-ingrowth glenoid components in TSA. However, no systematic review of the literature has been published to date. For this reason, the aims of this study were two-fold: (1) to determine the revision rate of all-polyethylene pegged bone-ingrowth glenoid components for aseptic loosening in TSA, and (2) to evaluate the postoperative radiologic findings in patients who underwent TSA with all-polyethylene pegged bone-ingrowth glenoid components.
Methods
A systematic review of the literature was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
Search criteria
The US National Library of Medicine (PubMed/MEDLINE), EMBASE, and the Cochrane Database of Systematic Reviews were queried for publications from the database inception date through 15 May 2020. An experienced medical librarian (BJ) developed and performed the search. The search criteria that were used for each database are presented in the supplementary Appendix. To maximize the search, backward chaining of reference lists from retrieved papers was also undertaken. Only abstracts that evaluated the utility of partially cemented all-polyethylene pegged bone-ingrowth glenoid components in TSA were reviewed.
Inclusion and exclusion criteria
The studies included were clinical trials investigating the outcome of anatomic TSA using partially cemented all-polyethylene glenoid components consisting of a circumferentially fluted, central, cementless, interference-fit peg for tissue integration and three small cemented peripheral pegs. Primary outcomes recorded and assessed included: (1) implant survivorship free of component revision and (2) overall rate of complications. Secondary outcomes included patient-reported outcome measures (PROMs), and radiographic assessments including radiolucent lines, metal debris, osteolysis, if reported, radiological evidence of glenoid component osseointegration.
The exclusion criteria were: (1) non-English language reports, (2) studies with less than 10 patients, (3) biomechanical studies, (4) studies using reverse shoulder arthroplasty or hemiarthroplasty, (5) studies using all-polyethylene fully cemented glenoid components, cementless metal-backed implants (either porous or highly porous or hybrid fixation of highly porous pegs/flanges with cemented polyethylene surface), (6) studies including augmented glenoid components, (7) studies without clinical, functional, or radiological outcomes, (8) general reviews and systematic reviews, (9) studies with results including mixed types of glenoid implants without stratification per type of component, (10) non full-text articles, and (11) studies with less than 24 months mean follow-up.
Data extraction
Two authors (MM, LK) independently conducted the search. All authors compiled a list of articles not excluded after application of the inclusion and exclusion criteria. In cases of disagreement, the senior author (EA) had the final decision. During initial review of the data, the following information was collected for each study: title, author, study design, number of patients, number of shoulders, gender, indication for surgery, type of glenoid component, PROMs, pain scores, health-related quality of life outcomes measures (HRQOL), range of motion (ROM), and finally all revisions, reoperations, and complications.
The level of evidence in the included studies was determined using the Oxford Centre for Evidence-Based Medicine-Levels of Evidence. 16 The methodological quality of each study and the different types of detected bias were assessed independently by each reviewer with the use of modified Coleman methodology score. 17 The modified Coleman Methodology score assesses the methodology of each study with use of 10 criteria, giving a total score between 0 and 100 (highest quality). Scores of 85 to 100 are considered excellent, 70 to 84 good, 55 to 69 fair, and less than 55 poor. The features of each article were separately assessed by two reviewers (MM and LK). The two investigators discussed scores where more than a two-point difference was evident until consensus was reached.
Results
Study selection
The literature search identified 116 abstracts related to the use of hybrid fixation glenoid components in TSA. Among those, 47 duplicate articles were identified and removed from the search. Following elimination of duplicate articles and predetermined exclusion criteria, the titles and the abstracts of the papers were screened and 15 papers were found eligible for full text screening. Two of these studies were excluded, because they dealt with non-partially cemented all-polyethylene implants (n = 1) and conference proceedings with no full text (n = 1). Finally, 13 articles were eligible for inclusion in the qualitative analysis.18–30 The corresponding PRISMA chart of the literature search results is shown in Figure 1.
Flow chart of study selection according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for reporting systematic reviews and meta-analyses.
Data synthesis
Study, patient, and treatment characteristics were summarized with the use of basic descriptive statistics. Radiolucency, osteolysis, and other radiologic changes were not counted as complications and we reported them separately under radiologic outcomes. For complications and radiologic findings, pooling was performed across studies and percentages were calculated.
Study characteristics
One study 25 was Level II, while 12 studies18–24,26–30 were Level IV.
Study characteristics.
Demographics
Patient demographics.
SD: standard deviation; M: male; F: female; NR: not reported.
Indication for surgery, type of implant, and bone graft
Among studies which reported indications for TSA, the most common reported indication for TSA was osteoarthritis (91.2%; 333 out of 365 cases). Other less common indications were post-traumatic arthritis (4.1%; 15 cases) humeral head avascular necrosis (1.6%; six cases), rheumatoid arthritis (1.6%; six cases) and conversion from failed hemiarthroplasty (0.8%; three cases).
All studies used standard deltopectoral approach either with subscapularis tenotomy or with osteotomy of the lesser tuberosity. The different implant designs used in the studies included in this systematic review were the following: Anchor Peg glenoid prosthesis (DePuy, Warsaw),18–24,27–29 Aequalis PERFORM (Tornier SAS, Montbonnot Saint Martin, France) 25 or Affiniti CortiLoc pegged glenoid (Tornier, Inc., Edina, MN, USA).26,30 Both the Anchor Peg glenoid prosthesis (first generation implant with 4 fins in the central peg) and the Aequalis PERFORM or Affiniti Cortiloc glenoid (both are similar second generation implants with 6 fins in the central peg) share a similar design of three peripheral polyethylene pegs and a flanged bone-ingrowth central peg. Moreover, all glenoid implants offer multiple backside curvatures to decrease excessive reaming of the glenoid. In all studies, minimal use of cement in the three peripheral pegs along with a cementless central bone-ingrowth peg was used to obtain hybrid fixation of the all-polyethylene glenoid component. Eleven studies18,20–24,26–30 used bone autograft obtained either from the drilled glenoid holes or the resected humeral head to impact it between the fins of the central peg in order to enhance bone ingrowth. Finally, two studies did not use any bone graft around the central peg.19,25
PROMs, pain scores, HRQOL, and ROM
Preoperative and postoperative patient-reported outcome measures (PROMs), pain scores, and health-related quality of life outcomes measures (HRQOL).
ASES: American Shoulder and Elbow Surgeons score (scale 0–100, 0 is worst); SST: Simple Shoulder Test score (scale 0–12, 0 is worst); CS: Constant score (scale 0–100, 0 is worst); VAS: Visual Analog Scale score (scale 0–10, 10 is worst); SF-12 PCS: 12-Item Short Form Health Survey questionnaire Physical Component Summary (scale 0–100, 0 is worst); NR: not reported.
Mean values are reported.
aMedian values are reported.
Preoperative and postoperative range of motion per study.
FF: forward flexion; ABD: abduction; ER-0: external rotation in 0° of abduction; ER-90: external rotation in 90 ° of abduction; NR: not reported.
Mean values are reported.
aMedian values are reported.
All postoperative mean scores as well as ROM measurements were found significantly better compared to their respective mean preoperative values.
Imaging outcomes
Complications (intraoperative and postoperative), reoperations, revisions, and radiographic glenoid findings.
rTSA: reverse total shoulder arthroplasty.
Intraoperative and postoperative complications
The overall rate of complications not requiring reoperations was 0.7% (4 complications in a total of 560 cases). Two studies reported having intraoperative complications.21,25 One case of glenoid fracture was treated with open reduction and internal fixation, followed by implantation of the glenoid prosthesis, 21 while two cases of intraoperative fractures (one humeral and one glenoid) required no further treatment. 25 The study of Vidil et al. 20 reported one case with persistent postoperative stiffness due to capsulitis (Table 5).
Reoperations and revisions
There was a total of seven reoperations reported, which accounted for 1.3% of the cases treated with partially cemented all-polyethylene central peg bone-ingrowth glenoid components. These comprised of two cases of instability (one case was treated with posterior capsule plication, and one case was treated with subscapularis repair and bone grafting), three cases of stiffness (one treated with hydrodilation and two with arthroscopical capsular release), one case with traumatic rupture of the subscapularis tendon treated with a pectoralis major tendon transfer, and one case of rotator cuff tear (repaired arthroscopically).
Revision surgery was required in 10 cases accounting for 1.8% of the operated cases. The reasons were: four cases of instability (all were revised to reverse TSA), two cases of subscapularis failures (revised to reverse TSA), two cases of infection (one case revised to reverse TSA, one case treated with resection arthroplasty after failed two-stage revision), and one case of periprosthetic humerus fracture along with infection (finally revised to reverse TSA). Finally, only one out of the 10 revisions (accounted for 0.2% of the overall population) was related to aseptic loosening of the glenoid component and was revised to a hemiarthroplasty (Table 5).
The only two studies19,27 that documented mid-term outcomes of partially cemented all-polyethylene central peg bone-ingrowth glenoid components had no reoperations.
All-polyethylene central fluted bone-ingrowth glenoid component versus cemented all-polyethylene pegged glenoid component
One prospective randomized study 25 compared radiographic lucency between a finned, cementless central pegged glenoid component (CL component) and a conventional cemented pegged glenoid component (P component) on immediate postoperative and minimum two-year follow-up radiographs. Out of the initial 54 patients, 42 (84%; 20 CL and 22 P) were available for follow-up (mean follow-up 35 months, range 24 to 64 months) with the original glenoid implant in place. There were no significant differences in glenoid radiolucency between CL (1/20 (5%)) and p (2/22 (9%)) components at last follow-up (p = .999), while no cases of aseptic glenoid loosening were reported among groups.
Discussion
In this systematic review of the literature of 560 cases treated with primary TSA containing partially cemented all-polyethylene pegged bone-ingrowth glenoid components, we found a high survivorship (98.2%) at short- to medium-term follow-up (two to six years), comparable to the historical survival rates of cemented all-polyethylene glenoid components reported in national registry studies.14,32 We found only one case of aseptic loosening of the glenoid component and no other complications associated with the glenoid side. In addition, mean clinical outcome measure scores as well as the different elements of ROM were significantly improved after surgery in all studies included in this analysis. Based on these findings, it is shown that partially cemented all-polyethylene pegged bone-ingrowth glenoid components produce promising results, with a low revision rate in the short- to medium-term follow-up. However, taking into consideration that there is no evidence yet regarding the long-term survivorship of these implants, we feel that further better designed clinical trials of longer follow-up should be conducted before definitive conclusions can be drawn concerning the longevity of partially cemented all-polyethylene pegged bone-ingrowth glenoid components.
Interestingly, based on the studies18–20,23–27,30 that graded radiographic lucencies around the glenoid component according to the Lazarus et al. 31 classification system, we found a high rate (34.1%) of implants with grade ≥2 radiolucencies. Approximately one out of three patients were found with postoperative radiolucency at the last follow-up (range two to six years). While most studies18,20,23,25,27 reported rates <20% and there was even one study 23 to report no radiolucencies (in 83 patients) at four-year mean follow-up, we found two studies26,30 with unacceptably high rates (>85%) of radiolucencies. Specifically, Merolla et al. 26 used a bone ingrowth central peg (with fins which received morselized bone graft) polyethylene glenoid component (Aequalis PERFORM Cortiloc™) to discover progressive radiolucencies in 28 out of 30 shoulders (93.3%) operated, although none of the glenoid components migrated in the short-term (mean follow-up 31 months). Furthermore, Parks et al. 30 assessed the outcome of a hybrid partially cemented pegged all-polyethylene glenoid implant that included a central peg with fins to receive bone autograft and to allow biologic fixation. They found that 88.2% of the operated shoulders (67 out of 76) had a grade 2 to 5 radiolucency at short-term (34 months mean follow-up). Although all these cases with glenoid component radiolucencies were asymptomatic and did not require any reoperation in the short- or medium-term follow-up, their alarmingly increased rate raise concern for potential failure of this glenoid component design in the long-term follow-up.
The overall rate of osteolysis around the central peg was 15.7%, based on the studies that reported this variable.21,22,24,26 In a radiostereometric analysis study, Nuttall et al. 28 found two patterns of migration for this type of component, the first showing little, if any, migration and the second showing rotation by >6 ° as early as three months post-operatively, suggesting that lack of initial stability in the cementless central peg leads to early movement and failure of osseointegration. At two years, these two groups could be confirmed on CT scans, one with osseointegration around the central peg, and the second with cystic changes. These findings raise also concern regarding the clinical use of these components, since they may suggest that lack of initial stability leads to early movement and failure of osseointegration.
There was very limited evidence of direct comparison between the outcomes of partially cemented all-polyethylene pegged bone-ingrowth glenoid components and cemented all-polyethylene glenoid components which are currently the gold standard option in TSA. We found only one relevant comparative study of level II 25 which divided patients into two groups: those with partially cemented all-polyethylene pegged bone-ingrowth glenoid components and those with cemented all-polyethylene components. The two patient cohorts, which had comparable baseline characteristics, did not show any significant differences in the rate of postoperative radiolucency at a minimum two-year follow-up, while there were no cases of aseptic loosening among groups. However, the follow-up of that study was very short, and these patients should be further followed to clarify if the partially cemented all-polyethylene pegged bone-ingrowth glenoid implant shows any superiority or inferiority to the cemented glenoid component in the long-term follow-up.
There are some limitations to this study. In this systematic review, there were no level I controlled trials, and all but one study (level II 25 ) were level IV case series. The lack of comparative studies makes it hard to determine if these implants offer any advantages over the traditional pegged implants. The quality of these studies was fair based on the modified Coleman methodology score and potential bias in the retrospective design of most studies might influence the results. Moreover, the studies varied widely regarding follow-up (short- to medium-term) and number of patients, while no long-term studies were included in this review. However, the type of treatment, outcome variables, and indication for surgery were clearly defined among studies. Finally, there might have been overlapping patients in the two studies by Nuttall et al.,28,29 but since the gender of the reported patients was not the same, we could not exclude any study. Despite not publishing a protocol prior to conducting this study, we believe that this comprehensive review of the literature is performed in a methodologically rigorous manner and provides insight into the use and outcomes of partially cemented all-polyethylene pegged bone-ingrowth glenoid components in TSA.
Conclusions
There was fair quality of evidence to show that partially cemented all-polyethylene pegged bone-ingrowth glenoid components in TSA produce promising results, with a low revision rate in the short-to medium-term follow-up. Nevertheless, this analysis identified high rates of both radiolucency of the glenoid component and osteolysis which raise concern for potential failure of this glenoid component in the long-term follow-up.
Footnotes
Acknowledgements
The authors would like to thank Ms Bridgett Jivanelli, medical librarian for her contribution in developing and performing the literature search.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Ethical Approval
This study was a systematic review of the literature. For this type of study, no IRB approval was required in our country.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Informed Consent
This study was a systematic review of the literature. For this type of study, no informed consent was required.
Guarantor
EA.
Contributorship
MM wrote the manuscript, conducted, and designed the study. LK participated in the acquisition and interpretation of data. IG wrote part of the manuscript. EC critically revised and edited the manuscript. EB critically revised and edited the manuscript. EA critically revised the manuscript and had its final checking. All authors read and approved the final manuscript.
