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

NCT04425603 | Completed FDA Device

• 1 other identifier: R11006-1
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

THR; Anthology Hip Replacement

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Harris Hip Score

  Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative

• Quality of life with Oxford Hip Score (postal)

  Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative

• Quality of life with EuroQol Questionnaire (EQ-5D)

  Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative

• Device-related complications

  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

Interventions

Anthology Hip Replacement System DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (4)

William Harvey Hospital East Kent NHS Trust

Ashford, TN24 0LZ, United Kingdom

Location

Ashford and St. Peter's NHS Trust

Chertsey, KT16 OPZ, United Kingdom

Location

South West London Elective Orthopaedic Centre (SWLEOC)

Epsom, KT18 7EG, United Kingdom

Location

Royal Berkshire NHS Foundation Trust

Reading, RG1 5AN, United Kingdom

Location

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: June 11, 2020
• Study Start: April 30, 2007
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)