Primary OsteoarthritisNCT04425603
Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study
An observational study of Primary Osteoarthritis and Secondary Osteoarthritis, run by Smith & Nephew Orthopaedics AG at 4 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Osteoarthritis, Secondary Osteoarthritis, Avascular Necrosis
- What is being tested?
- Anthology Hip Replacement System
- Type of treatment
- Medical device
- How many people
- 270 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 30 Apr 2007to 8 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
William Harvey Hospital East Kent NHS Trust
Ashford, TN24 0LZ
Ashford and St. Peter's NHS Trust
Chertsey, KT16 OPZ
South West London Elective Orthopaedic Centre (SWLEOC)
Epsom, KT18 7EG
Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN
About this 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.
Read the 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).
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Avascular Necrosis, Primary Total Hip Replacement (THR)
- Being tested
- Anthology Hip Replacement System
- Keywords
- THR, Anthology Hip Replacement
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthology Hip Replacement SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 10 years post operative
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
Number of revisions or withdrawals for any reason
Measured: 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.
Measured: 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.
Measured: 10 years post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start30 Apr 2007
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Field, MD, Principal investigator, South West London Elective Orthopaedic Centre (SWLEOC)Helmut Zahn, MD, Principal investigator, William Harvey Hospital East Kent NHS TrustPankaj Sharma, MD, Principal investigator, Ashford and St. Peter's NHS TrustTony Andrade, MD, Principal investigator, Royal Berkshire NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425603
- Sponsor's protocol ID
- R11006-1
- Status last verified
- Sep 2022
- First submitted
- 7 Jan 2020
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study
- ClinicalTrials.gov ID
- NCT04425603
- Acronym / sponsor ID
- R11006-1
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Avascular Necrosis, Primary Total Hip Replacement (THR)
- Keywords
- THR, Anthology Hip Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2007 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anthology Hip Replacement System | Device | – |
Primary outcome
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).
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.
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.
7 secondary outcomes
Harris Hip Score
Time frame: Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative
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
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
Device-related complications
Time frame: 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
Number of revisions or withdrawals for any reason
Time frame: 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
Radiographic evaluations
Time frame: Pre-operative, peri-operative, 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
Survival Rate
Time frame: 10 years post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Field, MD principal investigator
South West London Elective Orthopaedic Centre (SWLEOC)
Helmut Zahn, MD principal investigator
William Harvey Hospital East Kent NHS Trust
Pankaj Sharma, MD principal investigator
Ashford and St. Peter's NHS Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Osteoarthritis and Secondary Osteoarthritis, run by Smith & Nephew Orthopaedics AG at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score - 10 years (time frame: 10 years post operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.