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

A Consecutive Series Pilot Study Evaluating the Safety and Effectiveness of a New Hard-on-Hard Total Hip Replacement System in Patients With Non-inflammatory Arthritis With a Standard THA Metal Ion Control Group

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Degenerative
• Intervention / Treatment: Device: ODH Hip System

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Durban, South Africa, 4001
    • Entabeni Hospital
  • Pretoria, South Africa, 0002
    • Zuid Afrikaans Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Total Hip Replacement Device; 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)	Device: ODH Hip System; Other Names: Total Hip Replacement; Total Hip Arthroplasty; THA; THR
Experimental: Investigational Hard-on-Hard Total Hip Replacement Device; 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)	Device: ODH Hip System; Other Names: Total Hip Replacement; Total Hip Arthroplasty; THA; THR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Device-Related Revisions	Device related revisions reported by the number of participants with a revision required (Yes/No).	Postoperatively through 10 years
Metal Ion Concentration in Whole Blood	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.	3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only	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.	Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.
Hip Disability and Osteoarthritis Outcome Scores (HOOS)	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.	Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 years
Radiographic Measures: Radiolucencies	Radiolucencies determined by number of participants with occurrence of radiolucent lines and osteolysis (Yes/No)	3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Radiographic Measures: Heterotopic Ossification	Occurrence of Heterotopic Ossification in participants (Yes/No)	3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Radiographic Measures: Subsidence	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	3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Health Economic Outcomes: Surgical Blood Loss	Blood loss during surgery measured in milliliters (ml) of blood	Intra-operative, up to 50 minutes
Health Economic Outcomes: Length of Hospital Stay	Length of stay measured by number of days spent in hospital	Hospital admission to discharge
Health Economic Outcomes: Operative Time	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	Intra-operative
Health Economic Outcomes: Re-Hospitalizations	Re-hospitalizations measured by the number of re-admissions to hospital	Up to 10 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Andrew Baker, Entabeni Hospital; Principal Investigator: Johannes de Beer, Zuid Afrikaans Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2011
• Primary Completion (Actual): October 18, 2022
• Study Completion (Actual): October 18, 2022

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimated): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: total hip replacement (THR); total hip arthroplasty (THA)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 2011-ODHH166