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

Avascular Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04425603
• Other study ID #: R11006-1
• Status: Completed
• Start date: April 30, 2007
• Est. completion date: November 8, 2021

Study information

• Verified date: September 2022
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Anthology Hip Replacement System

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of revisions or withdrawals for any reason		6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
Secondary	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
Secondary	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