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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04425603
Recruitment Status : Completed
First Posted : June 11, 2020
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc. ( 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.

Condition or disease Intervention/treatment
Primary Osteoarthritis Secondary Osteoarthritis Avascular Necrosis Primary Total Hip Replacement (THR) 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).

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Study Type : Observational
Actual Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study
Actual Study Start Date : April 30, 2007
Actual Primary Completion Date : November 8, 2021
Actual Study Completion Date : November 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04425603


Locations
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United Kingdom
William Harvey Hospital East Kent NHS Trust
Ashford, United Kingdom, TN24 0LZ
Ashford and St. Peter's NHS Trust
Chertsey, United Kingdom, KT16 OPZ
South West London Elective Orthopaedic Centre (SWLEOC)
Epsom, United Kingdom, KT18 7EG
Royal Berkshire NHS Foundation Trust
Reading, United Kingdom, RG1 5AN
Sponsors and Collaborators
Smith & Nephew Orthopaedics AG
Investigators
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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
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Responsible Party: Smith & Nephew Orthopaedics AG
ClinicalTrials.gov Identifier: NCT04425603    
Other Study ID Numbers: R11006-1
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG ):
THR
Anthology Hip Replacement
Additional relevant MeSH terms:
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Osteoarthritis
Necrosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes