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No Increase in Survival for 36-mm versus 32-mm Femoral Heads in Metal-on-polyethylene THA

A Registry Study

Tsikandylakis, Georgios, MD; Kärrholm, Johan, MD, PhD; Hailer, Nils P., MD; Eskelinen, Antti, MD, PhD; Mäkelä, Keijo T., MD, PhD; Hallan, Geir, MD, PhD; Furnes, Ove Nord, MD, PhD; Pedersen, Alma B., DMSc, MD, PhD; Overgaard, Søren, MD, PhD; Mohaddes, Maziar, MD, PhD

Clinical Orthopaedics and Related Research®: December 2018 - Volume 476 - Issue 12 - p 2367–2378
doi: 10.1097/CORR.0000000000000508
CLINICAL RESEARCH
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Background During the past decade, the 32-mm head has replaced the 28-mm head as the most common head size used in primary THA in many national registries, and the use of 36-mm heads has also increased. However, it is unclear whether 32-mm and 36-mm heads decrease the revision risk in metal-on-polyethylene (MoP) THA compared with 28-mm heads.

Questions/purposes (1) In the setting of the Nordic Arthroplasty Register Association database, does the revision risk for any reason differ among 28-, 32-, and 36-mm head sizes in patients undergoing surgery with MoP THA? (2) Does the revision risk resulting from dislocation decrease with increasing head diameter (28-36 mm) in patients undergoing surgery with MoP THA in the same registry?

Methods Data were derived from the Nordic Arthroplasty Register Association database, a collaboration among the national arthroplasty registries of Denmark, Finland, Norway, and Sweden. Patients with primary osteoarthritis who had undergone primary THA with a 28-, 32-, or 36-mm MoP bearing from 2003 to 2014 were included. Patients operated on with dual-mobility cups were excluded. In patients with bilateral THA, only the first operated hip was included. After applying the inclusion criteria, the number of patients and THAs with a complete data set was determined to be 186,231, which accounted for 51% of all hips (366,309) with primary osteoarthritis operated on with THA of any head size and bearing type during the study observation time. Of the included patients, 60% (111,046 of 186,231) were women, the mean age at surgery was 70 (± 10) years, and the median followup was 4.5 years (range, 0-14 years). A total of 101,094 patients had received a 28-mm, 57,853 a 32-mm, and 27,284 a 36-mm head with 32 mm used as the reference group. The revision of any component for any reason was the primary outcome and revision for dislocation was the secondary outcome. Very few patients are estimated to be lost to followup because emigration in the population of interest (older than 65-70 years) is rare. A Kaplan-Meier analysis was used to estimate THA survival for each group, whereas Cox regression models were fitted to calculate hazard ratios (HRs) with 95% confidence intervals (CIs) for THA revision comparing the 28- and 36-mm head diameters with the 32-mm head diameters adjusting for age, sex, year of surgery, type of cup and stem fixation, polyethylene type (crosslinked versus conventional), and surgical approach.

Results In the adjusted Cox regression model, there was no difference in the adjusted risk for revision for any reason between patients with 28-mm (HR, 1.06; 95% CI, 0.97–0.16) and 32-mm heads, whereas the risk of revision was higher for patients with 36-mm heads (HR, 1.14; 95% CI, 1.04–1.26) compared with patients with 32-mm heads. Patients with 28-mm heads had a higher risk of revision for dislocation (HR, 1.67; 95% CI, 1.38–1.98) compared with 32 mm, whereas there was no difference between patients with 36-mm (HR, 0.85; 95% CI, 0.70–1.02) and 32-mm heads.

Conclusions After adjusting for relevant confounding variables, we found no benefits for 32-mm heads against 28 mm in terms of overall revision risk. However, when dislocation risk is considered, 32-mm heads would be a better option, because they had a lower risk of revision resulting from dislocation. There were no benefits with the use of 36-mm heads over 32 mm, because the transition from 32 to 36 mm was associated with a higher risk of revision for all reasons, which was not accompanied by a decrease in the risk of revision resulting from dislocation. The use of 32-mm heads appears to offer the best compromise between joint stability and other reasons for revision in MoP THA. Further studies with longer followup, especially of 36-mm heads, as well as better balance of confounders across head sizes and better control of patient-related risk factors for THA revision are needed.

Level of Evidence Level III, therapeutic study.

G. Tsikandylakis, J. Kärrholm, M. Mohaddes, Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Sahlgrenska University Hospital, Gothenburg, Sweden; and The Swedish Hip Arthroplasty Register, Gothenburg, Sweden

N. P. Hailer, Section of Orthopaedics, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden; and The Swedish Hip Arthroplasty Register, Gothenburg, Sweden

A. Eskelinen, Coxa Hospital of Joint Replacement, Tampere, Finland; and The Finnish Arthroplasty Register, Helsinki, Finland

K. T. Mäkelä, Department of Orthopedics and Traumatology, Turku University Hospital, Turku, Finland; and The Finnish Arthroplasty Register, Helsinki, Finland

G. Hallan, O. N. Furnes, The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway; and the Department of Clinical Medicine, Faculty of Medicine, University of Bergen, Bergen, Norway

A. B. Pedersen, Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; and The Danish Hip Arthroplasty Register, Aarhus, Denmark

S. Overgaard, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark; the Institute of Clinical Research, University of Southern Denmark, Odense, Denmark; and The Danish Hip Arthroplasty Register, Aarhus, Denmark.

G. Tsikandylakis, Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital/Mölndal R/4, Göteborgsvägen 31, SE-413 45 Gothenburg, Sweden, The Swedish Hip Arthroplasty Register, Registercentrum Västra Götaland, SE-413 45 Gothenburg 431, 30 Mölndal, Sweden, email: tsikandylakis@gmail.com

One of the authors (GT) has received research funding from the Göteborg Medical Society. The institution of one or more of the authors (GT, JK, MM) has received funding from the Felix Neubergh Foundation.

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.

Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use.

Each author certifies that his or her institution approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research.

This work was performed at various hospitals in Denmark, Sweden, Norway, and Finland. The data were processed in Gothenburg, Sweden.

Received May 08, 2018

Accepted September 05, 2018

© 2018 Lippincott Williams & Wilkins LWW
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