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

NCT02154516 | Completed Results

• 1 other identifier: 2011-ODHH166
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Arthritis, Degenerative

Keywords

total hip replacement (THR); total hip arthroplasty (THA)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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.

• Hip Disability and Osteoarthritis Outcome Scores (HOOS)

  Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 years

• Radiographic Measures: Radiolucencies

  3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative

• Radiographic Measures: Heterotopic Ossification

  3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative

• Radiographic Measures: Subsidence

  3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative

Study Arms (2)

Control Total Hip Replacement Device

ACTIVE COMPARATOR

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

Investigational Hard-on-Hard Total Hip Replacement Device

EXPERIMENTAL

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

Interventions

ODH Hip System DEVICE

Also known as: Total Hip Replacement, THR, Total Hip Arthroplasty, THA

Control Total Hip Replacement Device; Investigational Hard-on-Hard Total Hip Replacement Device

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (2)

Entabeni Hospital

Durban, 4001, South Africa

Location

Zuid Afrikaans Hospital

Pretoria, 0002, South Africa

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and Caveats

This study was initially conducted as a pilot study to assess early safety of the ODH on ODH Total Hip System in a small group of participants for up to two years. The study was then extended to include safety data for up to ten years. Imbalance of study arms and small sample size limits the amount of statistical conclusions the study can make. Not all data for Control participants were collected in every outcome measure, limiting the ability to compare the two arms.

Results Point of Contact

• Title: Clinical Study Manager
• Organization: Smith and Nephew

stephanie.rufo@smith-nephew.com

0499905851

Study Officials

• Andrew Baker

  Entabeni Hospital

  PRINCIPAL INVESTIGATOR

• Johannes de Beer

  Zuid Afrikaans Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: June 3, 2014
• Study Start: November 4, 2011
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2023-04

Locations

ZA (2)