Cup Position in Total Hip Arthroplasty with Standard Instruments
Research type
Research Study
Full title
Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty with Standard Instrumentation and Technique.
IRAS ID
248948
Contact name
M Thirumoolanathan
Contact email
Sponsor organisation
DePuy Synthes
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Summary of Research
DSJ_15010 : Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty with Standard Instrumentation and Technique
Acetabular cup positioning in total hip arthroplasty (THA) is thought to be closely related to performance.
The aim of this study is to find out how accurately surgeons can position an Acetabular cup (DePuy Synthes Pinnacle cup) with standard instruments and technique and compare planned acetabular cup position (cup inclination and version) preoperatively to actual cup position postoperatively as measured with plain films. Once collected, the data can be compared with data collected from implantations using different cup positioning instrumentation and techniques.
This is a global post market follow up study sponsored by DePuy Synthes, which will involve up to 15 sites worldwide and enrol 176 subjects. The sites selected to take part in the study are surgeons that are currently using the DePuy Synthes Total Hip Systems as part of their standard of care.
Patients requiring Total Hip Arthroplasty, (who meet all inclusion/exclusion criteria) and are indicated to receive the following devices; Pinnacle cup and either Corail® Hip System, Summit® Tapered Hip System or ActisTM Total Hip System stem for their THA which will be asked to participate in the study. The THA procedure will use standard cup placement instruments and techniques.
Information including patient reported outcomes, questionnaires, safety events and radiographs will be collected on these patients at the following timepoints: pre-operative, operative, immediate postoperative (discharge) 6, 12 and 52 weeks postoperatively.Summary of Results
Thank you for your participation in the total hip surgery cup positioning study. The following will provide a summary of the study results.
Study Title: Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty with Standard Instrumentation and Technique
Study Sponsor: Medical Device Business Services, Inc. – DePuy Synthes
Number of participants: 184
Locations of study sites: United Kingdom, United States, Italy, Netherlands
Why the research was needed: Cup positioning in total hip arthroplasty is thought to be closely related to performance. The aim of this study was to find out how accurately surgeons can position the cup with standard instruments and techniques.
The main questions studied: The primary purpose of the study was to review acetabular cup position success at 6 weeks postoperatively. Success was defined as cup inclination and version within 10 degrees of the surgeon plan. Other assessments included complications, patient reported outcomes (EQ-5D-5L, Forgotten Joint Score), and clinical outcomes (Harris Hip Score).Patient demographics: Mean age was 65.8 years. Gender was male for 36.8% and female for 63.2% of participants. Mean BMI was 29.7 kg/m2.
Complications/Adverse Events: One subject died due to an accident unrelated to their hip surgery. Eight fractures were reported: 3 greater trochanter, 3 acetabular, 1 pubic rami, 1 femoral. The other hip-related complications reported were dislocation (2; one recurrent), wound secretion and infection, treated with revision one day after surgery (1), wound infection (1), acetabular loosening (1), lower extremity numbness (1), foot drop (1), renal insufficiency (1), urosepsis (1).
Results of the study: Mean inclination at 6 weeks, surgeon target versus actual measured post-operatively, was 44.8 and 42.7 degrees. Mean version at 6 weeks, target versus actual, was 19.5 and 27.2 degrees. At the first post-operative visit (most at 6 week), cup positioning (inclination and version) was considered successful in 53.7% (80 of 149) of cases that were available for analysis. Inclination was successful in 83.9% (125 of 149) and version was successful in 63.5% (94 of 148) of cases at the first post-operative visit. The mean difference (in degrees) between surgeon target and post-operative measurement was -2.50 (SD 7.19) for inclination, and 7.70 (SD 5.96) for version. The mean Harris Hip Score was 51.3 preoperatively and 84.2 and 92.7 at 6- and 12-weeks post-operatively. Mean EQ-5D-5L scores were 0.59 preoperatively and 0.79 and 0.85 at 6- and 12-week respectively. Mean EQ-5D VAS was 67.9 preoperatively and 80.9 and 83.6 at 6- and 12-week respectively. The mean Forgotten Joint Score was 46.0 at 6-week and 63.4 at 12-week.
How this research has helped patients and researchers: This global multicenter study shows that current methods of predicting successful cup positioning is only accurate for version and inclination a combined 53.7% of the time. This study shows there is still room for improvement in helping surgeons accurately and consistently position the cup.
Further research planned: Additional research is planned to see if cup positioning can be improved in total hip arthroplasty.
Learn more about the study: Additional information about this study is posted on clinicaltrials.gov under the number NCT03189303.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: The study is not an applicable study with a required posting of results. The study has been posted on clinicaltrials.gov (NCT03189303). The Sponsor is actively seeking to publish results of the study in peer reviewed journals and have presented results at the EFORT congress in Lisbon, Portugal earlier this year (June 2022).REC name
South East Scotland REC 02
REC reference
19/SS/0060
Date of REC Opinion
25 Jun 2019
REC opinion
Further Information Favourable Opinion