Clinical trial NCT04989998: Patient Outcomes Using HIP7 Software as Compared to Conventional THA
Official title: A Prospective, Multi-center, Randomized Controlled Study to Evaluate Patient Outcomes Using Hip7 Software as Compared to Conventional Surgical Technique in S+N Total Hip Arthroplasties (THA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hip Replacement
Keywords: HIP7
Total Hip Arthroplasties (THA)
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Forgotten Joint Score (FJS)
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Change in Frequency of Reduction of Outliers
timeFrame: 6 weeks post surgery
measure: Patient Reported Outcomes: Hip Disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: 12 months post-surgery
measure: Patient Reported Outcomes: Oxford Hip Score (OHS)
timeFrame: 12 months post-surgery
measure: Patient Reported Outcomes: EuroQol (European Quality of Life) five-dimensional Five-level (EQ-5D-5L)
timeFrame: 12 months post-surgery
measure: Cup placement accuracy
timeFrame: 6 weeks post-op
measure: Assess Pelvic Tilt at 6 Weeks
timeFrame: 6 weeks post-op
measure: Assess Range of Motion of Femur at 6 Weeks
timeFrame: 6 weeks post-op
measure: Assess Frequency of Femur Head Dislocation at 6 Weeks
timeFrame: 6 weeks post-op
Other outcomes:
Locations:
Study officials:
affiliation: The Royal Orthopaedic Hospital NHS Foundation Trust
name: Edward T Davis, MB ChB, M.Sc, PGCME, FRCS(T&O)
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Jishuitan Hospital
name: Yixin Zhou
role: PRINCIPAL_INVESTIGATOR
References: