Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study

Completed

• Conditions: Secondary Osteoarthritis; Avascular Necrosis; Primary Osteoarthritis; Primary Total Hip Replacement (THR)

• Registration Number: NCT04425603
• Lead Sponsor: Smith & Nephew Orthopaedics AG

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2007-04-30
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-11
• Primary Completion: 2021-11-08
• Study Completion: 2021-11-08
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life with Oxford Hip Score (postal) - 10 years	10 years post operative	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.
Harris Hip Score - 10 years	10 years post operative	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).
Quality of life with EuroQol Questionnaire (EQ-5D) -10 years	10 years post operative	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life with Oxford Hip Score (postal)	Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative	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.
Quality of life with EuroQol Questionnaire (EQ-5D)	Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative	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.
Device-related complications	6 months, 3 years, 5 years, 7.5 years, and 10 years post operative	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
Radiographic evaluations	Pre-operative, peri-operative, 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative	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.
Survival Rate	10 years post operative	The survival rate will be calculated according to the method in accordance with Kaplan-Meier stating the 95% confidence interval.
Harris Hip Score	Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative	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).
Number of revisions or withdrawals for any reason	6 months, 3 years, 5 years, 7.5 years, and 10 years post operative

Trial Locations

Locations (4)

South West London Elective Orthopaedic Centre (SWLEOC); 🇬🇧 Epsom, United Kingdom

Royal Berkshire NHS Foundation Trust; 🇬🇧 Reading, United Kingdom

William Harvey Hospital East Kent NHS Trust; 🇬🇧 Ashford, United Kingdom

Ashford and St. Peter's NHS Trust; 🇬🇧 Chertsey, United Kingdom