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Completed

NCT Number: NCT04425603

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.

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Key information

Conditions

Primary Osteoarthritis Avascular Necrosis Bone Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Total Hip Replacement (THR) Secondary Osteoarthritis

Sex eligibility

All sexes

Study type

Observational

Primary location

William Harvey Hospital East Kent NHS Trust, Ashford, United Kingdom

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.
  • 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

  • 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.

Treatment and study plan

Anthology Hip Replacement System

Device

Primary outcomes

  1. Harris Hip Score - 10 years

    Time frame: 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).

  2. Quality of life with Oxford Hip Score (postal) - 10 years

    Time frame: 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.

  3. Quality of life with EuroQol Questionnaire (EQ-5D) -10 years

    Time frame: 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 outcomes

  1. Harris Hip Score

    Time frame: 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).

  2. Quality of life with Oxford Hip Score (postal)

    Time frame: 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.

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

    Time frame: 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.

  4. Device-related complications

    Time frame: 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

  5. Number of revisions or withdrawals for any reason

    Time frame: 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative

  6. Radiographic evaluations

    Time frame: 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.

  7. Survival Rate

    Time frame: 10 years post operative

    The survival rate will be calculated according to the method in accordance with Kaplan-Meier stating the 95% confidence interval.

Sponsors and collaborators

Lead sponsor

Smith & Nephew Orthopaedics AG

Industry

Registry information

Important dates

Study start
2007
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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