Patient Outcomes Using HIP7 Software as Compared to Conventional THA

NCT04989998 | Withdrawn FDA Device

• 1 other identifier: HIP7.2020.10
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is designed to demonstrate how Hip7 software can lead to improved patient outcomes compared to conventional procedures with standard instrumentation for total hip arthroplasties (THA) surgery.

Conditions

Hip Replacement

Keywords

HIP7; Total Hip Arthroplasties (THA)

Outcome Measures

Primary Outcomes (1)

• Forgotten Joint Score (FJS)

  Compare Forgotten Joint Score (FJS) utilizing Hip7 software on Kick \& CORI platforms with POLAR3 system to conventional procedures with standard instrumentation and digital templating techniques at 12 months post-operation. The FJS-12 Questionnaire comprises measures for assessment of joint-specific patient reported outcomes that focuses on subject's awareness of replaced joint in everyday life. Joint awareness defined as any unintended perception of a joint. Subjects rate awareness of their hip arthroplasty in 12 questions with a 5-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". Scores are summed \& linearly transformed in a 0-100 scale with a high value reflecting subject's ability to forget the replaced hip joint during daily living activities.

  12 months post-surgery

Secondary Outcomes (8)

• Change in Frequency of Reduction of Outliers

  6 weeks post surgery

• Patient Reported Outcomes: Hip Disability and Osteoarthritis Outcome Score (HOOS)

  12 months post-surgery

• Patient Reported Outcomes: Oxford Hip Score (OHS)

  12 months post-surgery

• Patient Reported Outcomes: EuroQol (European Quality of Life) five-dimensional Five-level (EQ-5D-5L)

  12 months post-surgery

• Cup placement accuracy

  6 weeks post-op

Study Arms (2)

Hip7 Software on Kick/ CORI platforms

EXPERIMENTAL

Subjects will receive total hip arthroplasty surgery using Hip7 on Kick or CORI platform utilizing R3 Polarstem implants.

Device: Hip7 Software on Kick/ CORI platforms

Conventional procedures with standard, manual instrumentation and digital templating techniques

ACTIVE COMPARATOR

Subjects will receive total hip arthroplasty surgery using conventional procedures with standard instrumentation and digital templating techniques utilizing R3 Polarstem implants.

Device: Conventional surgical procedures

Interventions

Hip7 Software on Kick/ CORI platforms DEVICE

Total hip arthroplasty surgery using Hip7 software on Kick or CORI platforms using R3 Polarstem implants.

Hip7 Software on Kick/ CORI platforms

Conventional surgical procedures DEVICE

THA surgery using standard, manual instrumentation and digital templating techniques using R3 polarstem implants.

Conventional procedures with standard, manual instrumentation and digital templating techniques

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject or legal guardian must provide written informed consent (reference section 7.5).
• Subjects eighteen (18) years or older and considered skeletally mature.
• Willing and able to make all required study visits.
• Able to follow instructions and deemed capable of completing the FJS, OHS, HOOS and EQ-5D-5L questionnaires.
• Subject requires a THA as a primary indication.
• Subject is a suitable candidate for implanting specific S+N implant system in the investigator's judgement.
• Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethics Committee (EC) approved informed consent form.
• Subject plans to be available through 12 months postoperative follow-up
• Routine radiographic assessment including CT and X-ray is possible.

You may not qualify if:

• Contraindicated for robotic THA or POLAR3 hip implant.
• Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
• Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
• Any subject that meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2011 Section 3.44.
• Subjects who have participated previously in this trial through THA on their other hip.
• Subjects with a history of poor compliance with medical treatment (i.e have mental illness, drug or alcohol addiction).
• Subjects who need a THA procedure on the index joint as a revision for a previously failed surgery.
• Subjects suspected to need bilateral surgery in the next 12 months.
• Subject has received THA on the opposing hip within the previous 6 months.
• Subjects not understanding the language used in the Informed Consent Form.
• Subjects with an active infection or sepsis (treated or untreated).
• Subjects morbidly obese with a BMI greater than 40.
• Subjects in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and are better suited for an alternate procedure.
• Subjects that have condition(s) that may interfere with the THA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
• Subjects, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Officials

• Edward T Davis, MB ChB, M.Sc, PGCME, FRCS(T&O)

  The Royal Orthopaedic Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Yixin Zhou

  Beijing Jishuitan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: August 4, 2021
• Study Start: September 30, 2021
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share