Patient Outcomes Using HIP7 Software as Compared to Conventional THA

NCT ID: NCT04989998

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2024-10-31

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.

Detailed Description

This study is a prospective, multi-center, randomized, controlled clinical study in total hip arthroplasties (THA) surgery. The subjects meeting the inclusion/exclusion criteria specified in the protocol will receive THA using either Hip7 software or conventional instrumentation.

The clinical follow-up evaluation will be performed preoperatively (Baseline), operatively, 6 weeks, 6 and 12 months after surgery using patient reported outcome measures regarding their general health, hip and physical abilities, quality of life and pain level.

Conditions

Hip Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hip7 Software on Kick/ CORI platforms

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

Group Type: EXPERIMENTAL

Hip7 Software on Kick/ CORI platforms

Intervention Type: DEVICE

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

Conventional procedures with standard, manual instrumentation and digital templating techniques

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

Group Type: ACTIVE_COMPARATOR

Conventional surgical procedures

Intervention Type: DEVICE

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

Interventions

Hip7 Software on Kick/ CORI platforms

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

Intervention Type: DEVICE

Conventional surgical procedures

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The subject or legal guardian must provide written informed consent (reference section 7.5).

2. Subjects eighteen (18) years or older and considered skeletally mature.

3. Willing and able to make all required study visits.

4. Able to follow instructions and deemed capable of completing the FJS, OHS, HOOS and EQ-5D-5L questionnaires.

5. Subject requires a THA as a primary indication.

6. Subject is a suitable candidate for implanting specific S+N implant system in the investigator's judgement.

7. 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.

8. Subject plans to be available through 12 months postoperative follow-up

9. Routine radiographic assessment including CT and X-ray is possible.

Exclusion Criteria

1. Contraindicated for robotic THA or POLAR3 hip implant.

2. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.

3. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.

4. Any subject that meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2011 Section 3.44.

5. Subjects who have participated previously in this trial through THA on their other hip.

6. Subjects with a history of poor compliance with medical treatment (i.e have mental illness, drug or alcohol addiction).

7. Subjects who need a THA procedure on the index joint as a revision for a previously failed surgery.

8. Subjects suspected to need bilateral surgery in the next 12 months.

9. Subject has received THA on the opposing hip within the previous 6 months.

10. Subjects not understanding the language used in the Informed Consent Form.

11. Subjects with an active infection or sepsis (treated or untreated).

12. Subjects morbidly obese with a BMI greater than 40.

13. 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.

14. 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).

15. Subjects, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.

16. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew Orthopaedics AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

The Royal Orthopaedic Hospital NHS Foundation Trust

Yixin Zhou

Role: PRINCIPAL_INVESTIGATOR

Beijing Jishuitan Hospital

Other Identifiers

HIP7.2020.10

Identifier Type: -

Identifier Source: org_study_id