TY - JOUR
T1 - A randomized prospective study comparing migration of hydroxyapatite and non-hydroxyapatite coated glenoid components using radiostereometric analysis
AU - Akhtar, Ahsan
AU - Ricks, Matthew
AU - Cunningham, Lindsay
AU - Moffatt, Maria
AU - Bale, Steve
AU - Walton, Michael
AU - Monga, Puneet
AU - Trail, Ian
N1 - Funding Information:
The study was undertaken in a single unit in the North West of England which specializes in shoulder arthroplasty. Ethical approval was provided by the local ethics committee (ref no: 13/NW/0357) and was sponsored and funded by Lima (Lima Corporate, Italy).
Funding Information:
Funding: This study was sponsored and funded by Lima , who manufactured the implants used in the study. Lima was not involved in data collection, data analysis, or the preparation of or editing of the manuscript.
Publisher Copyright:
© 2021 American Shoulder and Elbow Surgeons
PY - 2021/11/1
Y1 - 2021/11/1
N2 - Background: Primary shoulder arthroplasty can significantly improve quality of life; however, the glenoid baseplate remains the most common component to loosen, which may result in implant failure and subsequent revision surgery. Radiostereometric analysis (RSA) is considered the gold standard for accurate measurement of micro-motion between implant and bone. The aims of this study were to compare migration of the Lima SMR porous titanium hydroxyapatite (HA) coated and non-hydroxyapatite (non-HA) coated glenoid components through a prospective, randomized 2-arm trial using RSA, whilst also comparing clinical and functional outcomes. Methods: Twenty patients were randomized into 2 equal (HA and non-HA coated) groups with all patients undergoing primary anatomic shoulder arthroplasty, at which time tantalum beads were also inserted. RSA imaging was performed immediately postoperatively, then at 3, 6, 12, and 24 months postprocedure. These images were digitized and analyzed using model-based RSA software. All patients completed Oxford Shoulder Score (OSS), American Shoulder and Elbow Surgeons (ASES) score, Constant Score (CS) and Visual Analogue Scale (VAS) pain scores pre-and postoperatively at the aforementioned time points. Unpaired t-tests were used for clinical outcome data; Mann-Whitney U tests were used for RSA data. Significance levels were set at P <.05. Results: Mean age for the HA group was 72.3 years; 69.5 years for the non-HA group. Mean follow-up for both groups was above 36 months. No significant differences in glenoid migration were observed at each of the postoperative time points; the only exception being at 12 months (non-HA group displaying significantly greater rotation in the z-axis). The HA group displayed fractionally more translation in the x- and z-axes at all time points (not significant). Rotation in the z-axis was marginally greater at all postoperative time points in the non-HA group. Median total migration values revealed greater motion for the non-HA group at 3, 6, and 12 months (not significant). All clinical outcome measures improved significantly within each group; no statistical differences were observed between the groups for any outcome measure. One patient in each group underwent revision surgery to reverse shoulder arthroplasty due to unexplained pain (HA group) and cuff failure (non-HA group) only. Radiolucent lines were noted in 2 patients who are still under follow-up. Conclusion: This study has revealed promising early results of both HA coated and non-HA coated implants, however, hydroxyapatite coating of glenoid components does not significantly improve outcome scores nor provide extra stability compared to non-hydroxyapatite coated implants at 2 years postprocedure. Level of evidence: Level II; Randomized Controlled Trial
AB - Background: Primary shoulder arthroplasty can significantly improve quality of life; however, the glenoid baseplate remains the most common component to loosen, which may result in implant failure and subsequent revision surgery. Radiostereometric analysis (RSA) is considered the gold standard for accurate measurement of micro-motion between implant and bone. The aims of this study were to compare migration of the Lima SMR porous titanium hydroxyapatite (HA) coated and non-hydroxyapatite (non-HA) coated glenoid components through a prospective, randomized 2-arm trial using RSA, whilst also comparing clinical and functional outcomes. Methods: Twenty patients were randomized into 2 equal (HA and non-HA coated) groups with all patients undergoing primary anatomic shoulder arthroplasty, at which time tantalum beads were also inserted. RSA imaging was performed immediately postoperatively, then at 3, 6, 12, and 24 months postprocedure. These images were digitized and analyzed using model-based RSA software. All patients completed Oxford Shoulder Score (OSS), American Shoulder and Elbow Surgeons (ASES) score, Constant Score (CS) and Visual Analogue Scale (VAS) pain scores pre-and postoperatively at the aforementioned time points. Unpaired t-tests were used for clinical outcome data; Mann-Whitney U tests were used for RSA data. Significance levels were set at P <.05. Results: Mean age for the HA group was 72.3 years; 69.5 years for the non-HA group. Mean follow-up for both groups was above 36 months. No significant differences in glenoid migration were observed at each of the postoperative time points; the only exception being at 12 months (non-HA group displaying significantly greater rotation in the z-axis). The HA group displayed fractionally more translation in the x- and z-axes at all time points (not significant). Rotation in the z-axis was marginally greater at all postoperative time points in the non-HA group. Median total migration values revealed greater motion for the non-HA group at 3, 6, and 12 months (not significant). All clinical outcome measures improved significantly within each group; no statistical differences were observed between the groups for any outcome measure. One patient in each group underwent revision surgery to reverse shoulder arthroplasty due to unexplained pain (HA group) and cuff failure (non-HA group) only. Radiolucent lines were noted in 2 patients who are still under follow-up. Conclusion: This study has revealed promising early results of both HA coated and non-HA coated implants, however, hydroxyapatite coating of glenoid components does not significantly improve outcome scores nor provide extra stability compared to non-hydroxyapatite coated implants at 2 years postprocedure. Level of evidence: Level II; Randomized Controlled Trial
KW - Glenoid migration
KW - Hydroxyapatite
KW - Metal-backed glenoid
KW - Radiostereometric analysis
KW - Total shoulder arthroplasty
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U2 - 10.1053/j.sart.2021.04.001
DO - 10.1053/j.sart.2021.04.001
M3 - Article (journal)
AN - SCOPUS:85106590022
SN - 1045-4527
VL - 31
SP - 635
EP - 643
JO - Seminars in Arthroplasty JSES
JF - Seminars in Arthroplasty JSES
IS - 4
ER -