Clinical trial NCT04425603: Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study
Official title: Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Osteoarthritis
Secondary Osteoarthritis
Avascular Necrosis
Primary Total Hip Replacement (THR)
Keywords: THR
Anthology Hip Replacement
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 270
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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).

Eligibility 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.

Primary outcomes:
measure: Harris Hip Score - 10 years
timeFrame: 10 years post operative
measure: Quality of life with Oxford Hip Score (postal) - 10 years
timeFrame: 10 years post operative
measure: Quality of life with EuroQol Questionnaire (EQ-5D) -10 years
timeFrame: 10 years post operative
Secondary outcomes:
measure: Harris Hip Score
timeFrame: Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative
measure: Quality of life with Oxford Hip Score (postal)
timeFrame: Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative
measure: Quality of life with EuroQol Questionnaire (EQ-5D)
timeFrame: Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative
measure: Device-related complications
timeFrame: 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
measure: Number of revisions or withdrawals for any reason
timeFrame: 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
measure: Radiographic evaluations
timeFrame: Pre-operative, peri-operative, 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative
measure: Survival Rate
timeFrame: 10 years post operative
Other outcomes:
Locations:
city: Ashford
country: United Kingdom
facility: William Harvey Hospital East Kent NHS Trust
city: Chertsey
country: United Kingdom
facility: Ashford and St. Peter's NHS Trust
city: Epsom
country: United Kingdom
facility: South West London Elective Orthopaedic Centre (SWLEOC)
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
Study officials:
affiliation: South West London Elective Orthopaedic Centre (SWLEOC)
name: Richard Field, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: William Harvey Hospital East Kent NHS Trust
name: Helmut Zahn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ashford and St. Peter's NHS Trust
name: Pankaj Sharma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Berkshire NHS Foundation Trust
name: Tony Andrade, MD
role: PRINCIPAL_INVESTIGATOR
References: