Study protocol: The DAICY trial-dual versus single-antibiotic impregnated cement in primary hemiarthroplasty for femoral neck fracture-a register-based cluster-randomized crossover-controlled trial.

BACKGROUND AND PURPOSE: Older patients with a displaced femoral neck fracture (FNF) are often treated with a cemented primary hemiarthroplasty (HA). The DAICY trial investigates whether high-dose dual-impregnated antibioticloaded cement (DIAC) including gentamicin and clindamycin can reduce the risk of periprosthetic joint infection (PJI) in comparison with low-dose single-impregnated gentamicin antibiotic-loaded cement (SIAC), in patients ≥ 60 years treated with a cemented HA for a displaced FNF. STUDY DESIGN: The trial is a national, multicenter, register-based, cluster-randomized, crossover trial. Patients ≥ 60 years with a non-pathological, displaced FNF (Type Garden 3-4/AO 31-B2 or B3) suitable for HA according to local guidelines are eligible for inclusion. Participating orthopedic departments will be randomized to start with either SIAC (control group) or DIAC treatment (intervention group) for 2 years. After 2 years, the study departments will then change to the other treatment arm for the remaining 2 years of the study. Approximately 7,000 patients will be included. The study is pragmatic in that the choice of implant brands, surgical approach and peri- and postoperative protocols follow the local routines of each participating department. All outcome variables will be retrieved after linkage of the study cohort to the following Swedish registers: the Fracture Register, the Arthroplasty Register, the National Patient Register and the Prescribed Drug Registry Outcome: The primary outcome will be periprosthetic joint infection of the index joint within 1 year after surgery. Secondary outcomes will be any reoperation on the index joint, mortality within 90 days and 1 year, resistance patterns of causative bacteria in cases of PJI, and health economics. Potential added value: This trial is designed to support or refute the efficacy of DIAC used in patients with a displaced FNF, potentially reducing PJI and resource allocation. Start of the trial and estimated duration - The DAICY trial started recruiting patients in January 2022 and will continue recruiting for approximately 4 years. Complete follow-up expected in 5 years.

Hydroxyapatite coating does not improve uncemented stem survival after total hip arthroplasty!

BACKGROUND AND PURPOSE: It is still being debated whether HA coating of uncemented stems used in total hip arthroplasty (THA) improves implant survival. We therefore investigated different uncemented stem brands, with and without HA coating, regarding early and long-term survival. PATIENTS AND METHODS: We identified 152,410 THA procedures using uncemented stems that were performed between 1995 and 2011 and registered in the Nordic Arthroplasty Register Association (NARA) database. We excluded 19,446 procedures that used stem brands less than 500 times in each country, procedures performed due to diagnoses other than osteoarthritis or pediatric hip disease, and procedures with missing information on the type of coating. 22 stem brands remained (which were used in 116,069 procedures) for analysis of revision of any component. 79,192 procedures from Denmark, Norway, and Sweden were analyzed for the endpoint stem revision. Unadjusted survival rates were calculated according to Kaplan-Meier, and Cox proportional hazards models were fitted in order to calculate hazard ratios (HRs) for the risk of revision with 95% confidence intervals (CIs). RESULTS: Unadjusted 10-year survival with the endpoint revision of any component for any reason was 92.1% (CI: 91.8-92.4). Unadjusted 10-year survival with the endpoint stem revision due to aseptic loosening varied between the stem brands investigated and ranged from 96.7% (CI: 94.4-99.0) to 99.9% (CI: 99.6-100). Of the stem brands with the best survival, stems with and without HA coating were found. The presence of HA coating was not associated with statistically significant effects on the adjusted risk of stem revision due to aseptic loosening, with an HR of 0.8 (CI: 0.5-1.3; p = 0.4). The adjusted risk of revision due to infection was similar in the groups of THAs using HA-coated and non-HA-coated stems, with an HR of 0.9 (CI: 0.8-1.1; p = 0.6) for the presence of HA coating. The commonly used Bimetric stem (n = 25,329) was available both with and without HA coating, and the adjusted risk of stem revision due to aseptic loosening was similar for the 2 variants, with an HR of 0.9 (CI: 0.5-1.4; p = 0.5) for the HA-coated Bimetric stem. INTERPRETATION: Uncemented HA-coated stems had similar results to those of uncemented stems with porous coating or rough sand-blasted stems. The use of HA coating on stems available both with and without this surface treatment had no clinically relevant effect on their outcome, and we thus question whether HA coating adds any value to well-functioning stem designs.

Effects of hydroxyapatite coating of cups used in hip revision arthroplasty.

BACKGROUND AND PURPOSE: Coating of acetabular revision implants with hydroxyapatite (HA) has been proposed to improve ingrowth and stability. We investigated whether HA coating of revision cups can reduce the risk of any subsequent re-revision. METHODS: We studied uncemented cups either with or without HA coating that were used at a primary acetabular revision and registered in the Swedish Hip Arthroplasty Register (SHAR). 2 such cup designs were identified: Harris-Galante and Trilogy, both available either with or without HA coating. These cups had been used as revision components in 1,780 revisions of total hip arthroplasties (THA) between 1986 and 2009. A Cox proportional hazards model including the type of coating, age at index revision, sex, cause of cup revision, cup design, the use of bone graft at the revision procedure, and the type of cup fixation at primary THA were used to calculate adjusted risk ratios (RRs with 95% CI) for re-revision for any reason or due to aseptic loosening. RESULTS: 71% of the cups were coated with HA and 29% were uncoated. At a mean follow-up time of 6.9 (0-24) years, 159 (9%) of all 1,780 cups had been re-revised, mostly due to aseptic loosening (5%), dislocation (2%), or deep infection (1%). HA coating had no significant influence on the risk of re-revision of the cup for any reason (RR = 1.4, CI: 0.9-2.0) or due to aseptic loosening (RR = 1.1, 0.6-1.9). In contrast, HA coating was found to be a risk factor for isolated liner re-revision for any reason (RR = 1.8, CI: 1.01-3.3). Age below 60 years at the index cup revision, dislocation as the cause of the index cup revision, uncemented cup fixation at primary THA, and use of the Harris-Galante cup also increased the risk of re-revision of the cup. In separate analyses in which isolated liner revisions were excluded, bone grafting was found to be a risk factor for re-revision of the metal shell due to aseptic loosening (RR = 2.1, CI: 1.05-4.2). INTERPRETATION: We found no evidence to support the notion that HA coating improves the performance of the 2 studied cup designs in revision arthroplasty. In contrast, patient-related factors such as younger age and dislocation as the reason for cup revision, and technical factors such as the choice of revision cup were found to influence the risk of subsequent re-revision of the cup. The reason for inferior results after revision of uncemented cups is not known, but it is possible that these hips more often had pronounced bone loss at the index cup revision.

Effects of hydroxyapatite coating on survival of an uncemented femoral stem. A Swedish Hip Arthroplasty Register study on 4,772 hips.

BACKGROUND AND PURPOSE: Hydroxyapatite (HA) is widely used as a coating for uncemented total hip arthroplasty components. This has been suggested to improve implant ingrowth and long-term stability. However, the evidence behind the use of HA coating on femoral stems is ambiguous. We investigated survival of an uncemented, tapered titanium femoral stem that was available either with or without HA coating (Bi-Metric). PATIENTS AND METHODS: The stem had been used in 4,772 total hip arthroplasties (THAs) in 4,169 patients registered in the Swedish Hip Arthroplasty Register between 1992 and 2009. 59% of the stems investigated were coated with HA and 41% were uncoated. Kaplan-Meier survival analysis and a Cox regression model with adjustment for age, sex, primary diagnosis, and the type of cup fixation were used to calculate survival rates and adjusted risk ratios (RRs) of the risk of revision for various reasons. RESULTS: The 10-year survival rates of the HA-coated version and the uncoated version were about equal when we used revision for any reason as the endpoint: 98% (95% CI: 98-99) and 98% (CI: 97-99), respectively. A Cox regression model adjusting for the covariates mentioned above showed that the presence of HA coating did not have any influence on the risk of stem revision for any reason (RR = 1.0, 95% CI: 0.6-1.6) or due to aseptic loosening (RR = 0.5, CI: 0.2-1.5). There was no effect of HA coating on the risk of stem revision due to infection, dislocation, or fracture. INTERPRETATION: The uncemented Bi-Metric stem showed excellent 10-year survival. Our findings do not support the use of HA coating on this stem to enhance implant survival.

Increased risk of revision of acetabular cups coated with hydroxyapatite.

BACKGROUND: Hydroxyapatite (HA) is the main inorganic component of bone, and HA coating is widely used on acetabular cups in hip arthroplasty. It has been suggested that this surface finish improves cup survival. METHODS: All patients registered in the Swedish Hip Arthroplasty Register between 1992 and 2007 with an uncemented acetabular implant that was available either with or without HA coating were identified. 8,043 total hip arthroplasties (THAs) with the most common cup types (Harris-Galante, Romanus, and Trilogy) were investigated. A Cox regression model including type of coating, age, sex, primary diagnosis, cup type, and type of stem fixation was used to calculate adjusted risk ratios (RRs) for the risk of revision. RESULTS: HA coating was a risk factor for cup revision due to aseptic loosening (adjusted RR 1.7; 95% CI: 1.3-2). Age at primary arthroplasty of < 50 years, a diagnosis of pediatric hip disease, the use of a cemented stem, and the Romanus and Harris-Galante cup types were also associated with statistically significantly increased risk of cup revision due to aseptic loosening. INTERPRETATION: Our findings question the routine use of HA-coated cups in primary total hip arthroplasty. With some designs, this practice may even increase the risk of loosening-resulting in revision surgery.

Bone loss around a stable, partly threaded hydroxyapatite-coated cup: a prospective cohort study using RSA and DXA.

STUDY PURPOSE: Aseptic loosening of the acetabular component is the most common reason for revision after primary THA, and periprosthetic demineralisation has been described as a potential cause for this process. The trabeculae-oriented pattern (TOP)-cup is a flat, hydroxyapatite (HA)-coated titanium shell with a threaded rim that was developed in order to minimise periprosthetic bone loss. We hypothesised that this cup provides good primary stability and improves preservation of periprosthetic bone mineral density (BMD). BASIC PROCEDURES: A prospective cohort study on 30 patients receiving the TOP cup was carried out. Preoperative total hip BMD and postoperative periprosthetic BMD in five periprosthetic regions of interest were investigated by dual energy radiographic absorptiometry (DXA), cup migration was analysed by radiostereometry (RSA), and the Harris hips score (HHS) was determined. MAIN FINDINGS: Mean HHS increased from 49 (24-79) preoperatively to 99 (92-100) after two years. DXA after one year demonstrated substantial BMD loss in the proximal periprosthetic zones 1 (-18%), zone 2 (-16 %) and zone 3 (-9%, all p<0.001 when compared with baseline BMD determined immediately postoperatively). The bone loss in these regions did not recover after two years. RSA (performed on 16 patients) showed that only very limited micromotion of the implant occurred: Mean cranial migration was 0.01 mm (95% confidence interval (CI): -0.09-0.12) and mean inclination decreased by 0.02º (CI: -0.43-0.39) after two years. CONCLUSION: We conclude that the TOP cup provides good primary stability in the short-term. However, substantial BMD loss in proximal periprosthetic areas indicates that the design of this cup cannot prevent periprosthetic bone loss that has also been observed around other uncemented cups.