Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System

Not Applicable

Completed

Conditions: Arthritis, Degenerative

Interventions: Device: ODH Hip System

Registration Number: NCT02154516

Lead Sponsor: Smith & Nephew, Inc.

Brief Summary: The purpose of this study is to assess the early and long term safety and efficacy of the hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with non-inflammatory arthritis.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 26

Inclusion Criteria

At least 21 years old
Skeletally mature
Requires primary, unilateral total hip arthroplasty due to degenerative join disease
Preoperative Harris Hip Score of less than or equal to 70
Meets an acceptable preoperative medical clearance and is free or treated for conditions that would pose excessive operative risk
Given consent to participate in the study
Able to understand the purpose of the study, his/her role, and is available for follow-up

10 year extension:
- Subject has completed the 2 year primary study
- Subject has signed an Independent Ethics Committee (IEC) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope and possible consequences of the study have been explained in an understandable form
- Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through ten years post-operative follow-up

Exclusion Criteria

Diagnosis with high risk of Total Hip Arthroplasty (THA) failure
Requires bilateral THA
Requires revision of a prior hip replacement
Active infection or sepsis
History of local hip infection
Known metastatic or neoplastic disease
Conditions that may interfere with THA survival or outcomes
Need for structural bone grafts to support the implant
Contralateral lower extremity condition
Has other joint replacements or plans for other joint replacements within 2 years
Systemic steroid therapy within 3 months prior to surgery
Life expectancy less than 2 years
Intra-articular therapy within 6 months of enrollment
Female of child-bearing age not using contraception
Inadequate bone stock to support the device
Moderate to severe renal insufficiency
Emotional or neurological condition that would pre-empt ability or willingness to participate in the study
BMI >40
Above the knee amputation of the contralateral or ipsilateral leg
Known allergies to the components of the devices
Entered into another investigational study
Is a prisoner

10 year extension:

• In the opinion of the surgeon, the subject's health, safety or well-being may be compromised or harmed by continuation in the extension phase or participation may not be in the subject's best interests.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Total Hip Replacement Device	ODH Hip System	Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes: * R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem * OXINIUM heads on polyethylene liners or * Ceramic heads on ceramic liners (all uncemented components)
Investigational Hard-on-Hard Total Hip Replacement Device	ODH Hip System	Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes: * R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem * R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm) * R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm) * Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Device-Related Revisions	Postoperatively through 10 years	Device related revisions reported by the number of participants with a revision required (Yes/No).
Metal Ion Concentration in Whole Blood	3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.	For both investigational (i.e., Investigational Hard-on-Hard Total Hip Replacement Device) and control (i.e., Control Total Hip Replacement Device) participants, metal ion concentration in whole blood were measured for Cobalt (Co), Chromium (Cr), Nickel (Ni), Titanium (Ti), Zirconium (Zr), Niobium (Nb), Molybdenum (Mo), Vanadium (V) and Aluminum (Al) at each indicated time frame.

Secondary Outcome Measures

Name	Time	Method
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only	Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.	The Harris Hip Score (HHS), which ranges from 0 (worst) to 100 (best), considers information on pain, function, and range of motion. HHS was measured for Investigational Hard-on-Hard Total Hip Replacement Device only.
Hip Disability and Osteoarthritis Outcome Scores (HOOS)	Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 years	The Hip Disability and Osteoarthritis Outcome Scores (HOOS) was measured for Investigational Hard-on-Hard Total Hip Replacement Device only and included 40 items with five responses from five subcategories of Pain, Symptoms and Stiffness, Activities of Daily Living, Function in Sports and Recreational Activities, and Quality of Life to produce a total HOOS. The total HOOS scale ranged from 0 to 100, with 0 indicating the worst possible score and 100 indicating the best possible score.
Radiographic Measures: Radiolucencies	3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative	Radiolucencies determined by number of participants with occurrence of radiolucent lines and osteolysis (Yes/No)
Radiographic Measures: Heterotopic Ossification	3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative	Occurrence of Heterotopic Ossification in participants (Yes/No)
Radiographic Measures: Subsidence	3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative	Occurrence of Subsidence in Investigational Hard-on-Hard Total Hip Replacement Device participants (Yes/No) categorized by: * Acetabular Cup Subsidence * Stem Subsidence * Evidence of cortical thickening * Acetabular component fail * Femoral component fail * Other
Health Economic Outcomes: Surgical Blood Loss	Intra-operative, up to 50 minutes	Blood loss during surgery measured in milliliters (ml) of blood
Health Economic Outcomes: Length of Hospital Stay	Hospital admission to discharge	Length of stay measured by number of days spent in hospital
Health Economic Outcomes: Operative Time	Intra-operative	Operative time in minutes from first incision into skin to time when last suture is applied for the Investigational Hard-on-Hard Total Hip Replacement Device group only
Health Economic Outcomes: Re-Hospitalizations	Up to 10 years	Re-hospitalizations measured by the number of re-admissions to hospital