This clinical study will verify the clinical and radiographic performance of the prosthesis when used in human subjects over a period of 10 years. All complications will be documented.
The clinical evaluations will be based on standard, functional and pain parameters Harris Hip Score pre-operatively, and at 6 months, 3, 5, 7.5 and 10 years post-operatively. Postal Oxford questionnaire preoperatively, and yearly thereafter. The objective of this study is to analyse the clinical and radiographic responses and the complication rates for patients undergoing primary total hip arthroplasty using the Anthology Hip Replacement System (Anthology Hip System).
Study Type
OBSERVATIONAL
Enrollment
270
William Harvey Hospital East Kent NHS Trust
Ashford, United Kingdom
Ashford and St. Peter's NHS Trust
Chertsey, United Kingdom
South West London Elective Orthopaedic Centre (SWLEOC)
Epsom, United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, United Kingdom
Harris Hip Score - 10 years
The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).
Time frame: 10 years post operative
Quality of life with Oxford Hip Score (postal) - 10 years
Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has five possible responses. In the original scoring responses were from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome.
Time frame: 10 years post operative
Quality of life with EuroQol Questionnaire (EQ-5D) -10 years
The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Time frame: 10 years post operative
Harris Hip Score
The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative
Quality of life with Oxford Hip Score (postal)
Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has five possible responses. In the original scoring responses were from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome.
Time frame: Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative
Quality of life with EuroQol Questionnaire (EQ-5D)
The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Time frame: Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative
Device-related complications
Complications and adverse events will be noted at each follow-up and using clinical judgement it will be determined whether the event is device related
Time frame: 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
Number of revisions or withdrawals for any reason
Time frame: 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
Radiographic evaluations
Anterior-posterior, and lateral view x-rays of the femur and pelvis of the affected hip will be evaluated. X-rays will be reviewed and specific information regarding presence/absence/location of radiolucent lines and implant positions and alignment will be recorded.
Time frame: Pre-operative, peri-operative, 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
Survival Rate
The survival rate will be calculated according to the method in accordance with Kaplan-Meier stating the 95% confidence interval.
Time frame: 10 years post operative