Safety and Efficacy of Hemispherical with Flattened Pole Dual-Mobility Acetabular Cup in Revision or Complex Hip Arthroplasty: The SYMCOR-2 study

2020 ◽  
Author(s):  
Gilles Estour ◽  
Nicolas Bonin ◽  
Schneider Loïc ◽  
Olivier Guyen ◽  
Frederic Christopher Daoud
Keyword(s):  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Cobalt Chromium ◽  
Sampling Frame ◽  
Acetabular Cup ◽  
Short Term ◽  
Dual Mobility ◽  
Safety And Efficacy ◽  
Total Hip

Abstract Background: This study estimated the short-term clinical safety and efficacy of hemispherical with flattened pole cobalt-chromium metal-back dual-mobility acetabular cup with porous outer hydroxyapatite coating and anchoring screw and pods (HFPC-DMR-HA) or cement fixation (HFPC-DM-CEM), in revision or complex total hip arthroplasty.Methods: Single-center retrospective observational cohort study of consecutively operated patients who underwent THA with an HFPC-DMR-HA or HFPC-DM-CEM cup 2 years prior to study start. Prospective 2-year follow-up with letter and phone questionnaires.Results: Sampling frame: 203 patients including 9.85% in the two cohorts with 15 HFPC-DMR-HA and 5 HFPC-DM-CEM. 3 (20%) and 2 (40%) patients were lost to follow-up, respectively. Median age was 85.6 years (range: 45.1 ; 93.3) and 78.8 (range: 68.8 ; 86.9). Median follow-up (years): HFPC-DMR-HA: 2.3, HFPC-DM-CEM: 3.3. Clinical indications: HFPC-DMR-HA 67% revision & 33% primary THAs, HFPC-DM-CEM 100% revision. Primary endpoint: 2-year implant survival rate: HFPC-DMR-HA 93% [59, 99], HFPC-DM-CEM 100%. Prosthetic dislocation: HFPC-DMR-HA 1 (6.7%), HFPC-DM-CEM 0%. Secondary endpoint: Modified HHS (pain & functional subscore) improved with HFPC-DMR-HA from baseline 26.8 [14.9, 38.7] to 82.2 [73.5, 90.9] at 2-year follow-up (p<0.0001); HFPC-DM-CEM from 41.6 [24.9, 58.3] to 80.7 [55.8, 100].Conclusions: The authors deemed the short-term outcomes with these acetabular cups in revision or complex total hip arthroplasty to be satisfactory.Study registration: clinicaltrials.gov NCT04209426.

scholarly journals Safety and Efficacy of Hemispherical with Flattened Pole Dual-Mobility Acetabular Cup in Revision or Complex Hip Arthroplasty: The SYMCOR-2 study

2020 ◽  
Author(s):  
Gilles Estour ◽  
Nicolas Bonin ◽  
Schneider Loïc ◽  
Olivier Guyen ◽  
Frederic Christopher Daoud
Keyword(s):  
Hip Arthroplasty ◽  
Cobalt Chromium ◽  
Sampling Frame ◽  
Acetabular Cup ◽  
Short Term ◽  
Clinical Safety ◽  
Dual Mobility ◽  
Safety And Efficacy ◽  
Total Hip

Abstract Background: This study estimated the short-term clinical safety and efficacy of hemispherical with flattened pole cobalt-chromium metal-back dual-mobility acetabular cup with porous outer hydroxyapatite coating and anchoring screw and pods (HFPC-DMR-HA) or cement fixation (HFPC-DM-CEM), in revision or complex total hip arthroplasty.Methods: Single-center retrospective observational cohort study of consecutively operated patients who underwent THA with an HFPC-DMR-HA or HFPC-DM-CEM cup 2 years prior to study start. Prospective 2-year follow-up with letter and phone questionnaires.Results: Sampling frame: 203 patients including 9.85% in the two cohorts with 15 HFPC-DMR-HA and 5 HFPC-DM-CEM. 3 (20%) and 2 (40%) patients were lost to follow-up, respectively. Median age was 85.6 years (range: 45.1 ; 93.3) and 78.8 (range: 68.8 ; 86.9). Median follow-up (years): HFPC-DMR-HA: 2.3, HFPC-DM-CEM: 3.3. Clinical indications: HFPC-DMR-HA 67% revision & 33% primary THAs, HFPC-DM-CEM 100% revision. Primary endpoint: 2-year implant survival rate: HFPC-DMR-HA 93% [59, 99], HFPC-DM-CEM 100%. Prosthetic dislocation: HFPC-DMR-HA 1 (6.7%), HFPC-DM-CEM 0%. Secondary endpoint: Modified HHS (pain & functional subscore) improved with HFPC-DMR-HA from baseline 26.8 [14.9, 38.7] to 82.2 [73.5, 90.9] at 2-year follow-up (p<0.0001); HFPC-DM-CEM from 41.6 [24.9, 58.3] to 80.7 [55.8, 100].Conclusions: The authors deemed the short-term outcomes with these acetabular cups in revision or complex total hip arthroplasty to be satisfactory.Study registration: clinicaltrials.gov NCT04209426.

scholarly journals Safety and Efficacy of Hemispherical with Flattened Pole Dual-Mobility Acetabular Cup in Primary Hip Arthroplasty: The SYMCOR-1 study

2020 ◽  
Author(s):  
Nicolas Bonin ◽  
Gilles Estour ◽  
Jean-Emmanuel Gedouin ◽  
Olivier Guyen ◽  
Frederic Christopher Daoud
Keyword(s):  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Cobalt Chromium ◽  
Acetabular Cup ◽  
Short Term ◽  
Dual Mobility ◽  
Safety And Efficacy ◽  
Total Hip ◽  
Primary Total Hip Arthroplasty

Abstract Background: This study estimated the short-term clinical safety and efficacy of hemispherical with flattened pole cobalt-chromium metal-back with porous outer hydroxyapatite coating dual-mobility acetabular cup (HFPC-DM-HA) in primary total hip arthroplasty.Methods: Single-center retrospective observational cohort study of consecutive patients undergoing total hip arthroplasty with a HFPC-DM-HA 2 years prior to study start. Prospective 2-year follow-up with letter and phone questionnaires.Results: Sampling frame: 361 patients including 59 patients (16.3%) in the cohort. 6 patients (10%) lost to follow-up. Median age 77.5 years (range: 67 ; 92), 32% female, median BMI 25.2 kg.m-2 (18.4 to 56.8). Clinical indications: Primary THA in all patients, resulting from primary osteoarthritis in 80% of them. Median follow-up 3.0 years (2.7 to 4.1). Primary endpoint: 2-year implant survival rate: 97% [87, 99]. Prosthetic dislocation: 0%. Secondary endpoint: Modified HHS (pain & functional subscore) improved from baseline 39.7 [34.6, 44.7] to 75.8 [72.1, 79.6] at 1-year and to 86.7 [83.7, 89.7] at 2-year follow-up (p<0.0001).Conclusions: The authors deemed the short-term outcomes of this acetabular cup in primary total hip arthroplasty to be satisfactory.Study registration: clinicaltrials.gov NCT04209374.

Do Cemented Dual-Mobility Cups Confer Stability for Patients at High Risk of Dislocation in Revision Total Hip Arthroplasty?

2018 ◽  
Vol 02 (02) ◽  
pp. 088-091 ◽  
Author(s):  
Perry Evangelista ◽  
Kamil Okroj ◽  
Darren Plummer ◽  
Craig Della Valle ◽  
Ran Schwarzkopf
Keyword(s):  
High Risk ◽  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Revision Surgery ◽  
Revision Total Hip Arthroplasty ◽  
Acetabular Cup ◽  
Metal Shell ◽  
Dual Mobility ◽  
Total Hip

AbstractDislocation is among the most commonly reported complications following revision total hip arthroplasty. Dual-mobility bearings may lower the risk of dislocation. The authors report the results of a multicenter study evaluating the use of a dual-mobility acetabular cup design that was cemented into a metal shell as part of complex acetabular reconstructions or in cases where the risk of dislocation was felt to be high, such as isolated bearing exchanges. Eighteen patients were identified for being at high risk of dislocation who underwent cementation of a dual-mobility shell that is specifically made for cementation, into a fully porous metal revision acetabular cup (10 patients) or into a well-fixed cup at the time of revision without removal of the existing acetabular component (eight patients). Patients were assessed clinically and radiographically at a minimum of 2 years for the evidence of dislocation, revision surgery, and implant loosening. At a mean of 36 months (range, 25–56 months), one patient died and one was lost to follow-up. There were no known cases of hip dislocation. There was one repeat revision, for a deep infection treated with irrigation and debridement. The mean preoperative Harris Hip Score of 46 (range, 40–79) improved to a mean of 65 points (range, 41–97) at the most recent evaluation. Acetabular components were retained in 8 out of 18 cases and the dual-mobility shell was cemented into it. Cementation of a dual-mobility cup into a shell at the time of a revision surgery is a safe and reliable construct at minimum of 2 years for patients at high risk of dislocation. There were no complications related to the cementation of the cup into the metal shell. Longer follow-up is required to further assess the durability of this construct.

scholarly journals Hemispherical with Flattened Pole Dual-Mobility Acetabular Cup in Revision or Complex Hip Arthroplasty: Safety and Efficacy. The SYMCOR-2 study [NCT04209426]

2021 ◽  
Vol 4 (3) ◽  
Keyword(s):  
Cobalt Metal ◽  
Sampling Frame ◽  
Acetabular Cup ◽  
Short Term ◽  
Clinical Safety ◽  
Dual Mobility ◽  
Safety And Efficacy ◽  
Observational Cohort ◽  
Lost To Follow Up

Purpose: To Estimate the short-term clinical safety and efficacy of hemispherical with flattened pole chromium-cobalt metal back dual-mobility acetabular cups with porous outer coating and anchoring (HFPC-DMR-HA) or cement fixation (HFPCDM-CEM), in revision or complex THA. Methods: Single-centre retrospective observational cohort study (title: SYMCOR-2, clinicaltrials.gov: NCT04209426) of consecutively operated patients who underwent THA with an HFPC-DMR-HA or HFPC-DM-CEM cup 2 years prior to study start. Prospective 2-year follow-up with letter and phone questionnaires. Results: Sampling frame: 203 patients including 9.85% in the two cohorts with 15 HFPC-DMR-HA and 5 HFPC-DM-CEM. 30% lost to follow-up. Median follow-up (years): HFPC-DMR-HA: 2.3, HFPC-DM-CEM: 3.3. Indications: HFPC-DMR-HA 67% revision & 33% primary THAs, HFPC-DM-CEM 100% revision. Primary endpoint: 2-year implant survival rate: HFPC-DMR-HA 93% [59, 99], HFPC-DM-CEM 100%. Prosthetic dislocation: HFPC-DMR-HA: 1 (6.7%), HFPC-DM-CEM: 0%. Secondary endpoint: Modified HHS (pain & functional sub score) improved with HFPC-DMR-HA from baseline 26.8 [14.9, 38.7] to 82.2 [73.5, 90.9] at 2-year follow-up (p<0.0001), HFPC-DM-CEM from 41.6 [24.9, 58.3] to 80.7 [55.8, 100]. Conclusions: The short-term benefit-risk balance was deemed satisfactory

scholarly journals Dislocation Rate at Short-term Follow-up after Revision Total Hip Arthroplasty with a Dual Mobility Component

2016 ◽  
Vol 6 (1) ◽  
pp. 17-20 ◽  
Author(s):  
Samuel S Wellman ◽  
David E Attarian ◽  
Taylor R McClellan ◽  
Roberto D Calderon ◽  
Paul F Lachiewicz
Keyword(s):  
Total Hip Arthroplasty ◽  
Acetabular Component ◽  
Hip Arthroplasty ◽  
Dislocation Rate ◽  
Revision Total Hip Arthroplasty ◽  
Short Term ◽  
Dual Mobility ◽  
Total Hip ◽  
Increased Risk

ABSTRACT Patients undergoing a revision total hip arthroplasty (THA) are at increased risk for dislocation. The literature suggests dual-mobility components may decrease the frequency of dislocation. We conducted a retrospective study of one type of dual mobility acetabular component implanted in 82 revision THA cases that were considered at increased risk for dislocation. Of the 82 hips, 58 had a mean follow-up of 12 months (3–28 months). The indication for revision was instability in 18 hips (31%), adverse metal-on-metal reaction in 13 hips (22%), reimplantation for infection in 11 hips (19%), and aseptic loosening of the acetabular component in 9 hips (16%). In the course of follow-up, 6 hips developed a deep infection requiring reoperation. There were no early hip dislocations. McClellan TR, Calderon RD, Bolognesi MP, Attarian DE, Lachiewicz PF, Wellman SS. Dislocation Rate at Short-term Follow-up after Revision Total Hip Arthroplasty with a Dual Mobility Component. The Duke Orthop J 2016;6(1):17-20.

scholarly journals Dual-Mobility Progressive Press-Fit Hemispherical Acetabular Cup in Primary Hip Arthroplasty: Safety and Efficacy. The SYMCOR-1 study [NCT04209374]

2021 ◽  
Vol 4 (3) ◽  
Keyword(s):  
Cobalt Metal ◽  
Sampling Frame ◽  
Acetabular Cup ◽  
Short Term ◽  
Clinical Safety ◽  
Dual Mobility ◽  
Safety And Efficacy ◽  
Press Fit ◽  
Lost To Follow Up

Purpose: To Estimate the short-term clinical safety and efficacy of hemispherical with flattened pole chromium-cobalt metal back dual-mobility acetabular cup with porous outer coating (HFPC-DM-HA), in primary THA. Methods: Single-center retrospective observational cohort study of consecutive patients undergoing THA with a HFPC-DMHA cup 2 years prior to study start. Prospective 2-year follow-up with letter and phone questionnaires. Results: Sampling frame: 361 patients including 59 patients (16.3%) in the cohort. 6 patients (10%) lost to follow-up. Median age 77.5 years (67, 92), 32% female, median BMI 25.2 kg.m-2 (18.4 to 56.8). Primary osteoarthritis in 80%. Median follow-up 3.0 years (2.7 to 4.1) Primary Endpoint: 2-year implant survival rate: 97% [87, 99]. Prosthetic dislocation: 0%. Secondary Endpoint: Modified HHS (pain & functional sub score) improved from baseline 39.7 [34.6, 44.7] to 75.8 [72.1, 79.6] at 1-year and to 86.7 [83.7, 89.7] at 2-year (p<0.0001). Conclusions: The short-term benefit-risk balance was deemed satisfactory

Safety of vitamin E-infused highwall liners for routine use in primary total hip arthroplasty: single centre, short-term follow-up of 1221 cases

2020 ◽  
pp. 112070002096964
Author(s):  
Kirill Gromov ◽  
Nanna H Sillesen ◽  
Thomas Kallemose ◽  
Henrik Husted ◽  
Henrik Malchau ◽  
...  
Keyword(s):  
Patient Safety ◽  
Vitamin E ◽  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Single Centre ◽  
Short Term ◽  
Total Hip ◽  
Arthroplasty Registry ◽  
Primary Total Hip Arthroplasty

Background: Introduction of new implants should be monitored closely to capture any signs of compromising patient safety. Vitamin E infused highly-crosslinked polyethylene liners (VEPE) offer the potential for reduced wear. Highwall liners have been hypothesised to result in increased wear and potential liner fractures. The aim of this study was to determine the 3–7-year follow-up of highwall VEPE for primary total hip arthroplasty (THA), focusing on liner-related complications. Methods: We included 1221 consecutive THA operations from July 2010 to May 2014 with minimum follow-up of 3 (3.1–6.8) years Data collected included demographics, implant data, complications, reoperations, and deaths. Data were cross-referenced with the Danish Hip Arthroplasty Registry in order to ensure validity and completeness. Acetabular shell position was measured using Martell Hip Analysis Suite in a subgroup of 931 THAs. Results: Cumulative stem revision and shell revision at 3-year follow-up was 3.4% and 0.4% respectively. There were no revisions due to liner failure. Reason for revision included 11 dislocations, 15 soft-tissue revisions for infection, 44 stem revisions of which 34 were periprosthetic fractures and 13 shell revisions of which 6 were combined shell and stem revisions. Conclusion: Early follow-up of VEPE liners for primary THA have not shown any revisions associated with liner failure. Continued monitoring of new materials are necessary to capture any signs of compromised patient safety.

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