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

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.

Study Overview

• Status: Completed
• Conditions: Avascular Necrosis; Primary Osteoarthritis; Secondary Osteoarthritis; Primary Total Hip Replacement (THR)
• Intervention / Treatment: Device: Anthology Hip Replacement System

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 Type: Observational
• Enrollment (Actual): 270

Contacts and Locations

Study Locations

• United Kingdom
  • Ashford, United Kingdom, TN24 0LZ
    • William Harvey Hospital East Kent NHS Trust
  • Chertsey, United Kingdom, KT16 OPZ
    • Ashford and St. Peter's NHS Trust
  • Epsom, United Kingdom, KT18 7EG
    • South West London Elective Orthopaedic Centre (SWLEOC)
  • Reading, United Kingdom, RG1 5AN
    • Royal Berkshire NHS foundation trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Those presenting with primary or secondary osteoarthritis or avascular necrosis of the femoral head or patients suitable for a primary total hip replacement (THR).

Description

Inclusion criteria:

1. Those presenting with primary or secondary osteoarthritis or avascular necrosis of the femoral head or patients suitable for a primary total hip replacement. This is the patient group that will benefit from operative surgery to treat osteoarthritis.
2. Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme. Patients capable of giving informed consent are eligible for inclusion into the study.
3. Participants who signed the Ethics Committee approved specific Informed Consent Form prior to surgery. Patients who have not given informed consent will not be eligible for inclusion into the study.

Exclusion criteria:

1. Patients whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
2. Patients not suitable for primary hip replacement.
3. Patients with active or suspected infection.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	10 years post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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	6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
Number of revisions or withdrawals for any reason		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.	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.	10 years post operative

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Principal Investigator: Richard Field, MD, South West London Elective Orthopaedic Centre (SWLEOC); Principal Investigator: Helmut Zahn, MD, William Harvey Hospital East Kent NHS Trust; Principal Investigator: Pankaj Sharma, MD, Ashford and St. Peter's NHS Trust; Principal Investigator: Tony Andrade, MD, Royal Berkshire NHS foundation trust

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2007
• Primary Completion (Actual): November 8, 2021
• Study Completion (Actual): November 8, 2021

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: THR; Anthology Hip Replacement
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Necrosis
• Other Study ID Numbers: R11006-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes