Arthritis, DegenerativeNCT02154516

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

A study testing ODH Hip System in people with Arthritis, Degenerative, run by Smith & Nephew, Inc. at 2 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Arthritis, Degenerative
What is being tested?: ODH Hip System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 2 sitesSouth Africa
Study dates: 4 Nov 2011to 18 Oct 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

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

Show all 24Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

Entabeni Hospital
Durban, 4001
Zuid Afrikaans Hospital
Pretoria, 0002

Other trials in South Africa

About this study

Official title: 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

Conditions: Arthritis, Degenerative
Being tested: ODH Hip System
Keywords: total hip replacement (THR), total hip arthroplasty (THA)
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ODH Hip SystemDevice
Also called Total Hip Replacement, THR, Total Hip Arthroplasty, THA

Study groups in NCT02154516
Study group	Role	What they receive
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) Receives: 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) Receives: Device: ODH Hip System

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Device-Related Revisions
Device related revisions reported by the number of participants with a revision required (Yes/No).
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Intra-operative, up to 50 minutes
Health Economic Outcomes: Length of Hospital Stay
Length of stay measured by number of days spent in hospital
Measured: 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
Measured: Intra-operative
Health Economic Outcomes: Re-Hospitalizations
Re-hospitalizations measured by the number of re-admissions to hospital
Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 201118 Oct 2022

First posted3 Jun 2014 (estimated)
Study start4 Nov 2011
Primary completion18 Oct 2022
Study completion18 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Arthritis, DegenerativeStudies of the same condition, open and under way.
More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02154516
Sponsor's protocol ID: 2011-ODHH166
Status last verified: Apr 2023
First submitted: 13 May 2014
Last updated: 6 Dec 2024
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Arthritis, Degenerative trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02154516
Acronym / sponsor ID: 2011-ODHH166
Conditions: Arthritis, Degenerative
Keywords: total hip replacement (THR), total hip arthroplasty (THA)
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 4 Nov 2011 (actual)
Primary completion: 18 Oct 2022 (actual)
Study completion: 18 Oct 2022 (actual)
First posted: 3 Jun 2014 (estimated)
Results: Posted 6 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control Total Hip Replacement Device	Active comparator	Device: ODH Hip SystemTotal 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	Experimental	Device: ODH Hip SystemTotal 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)

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (24 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ODH Hip SystemAlso: Total Hip Replacement, THR, Total Hip Arthroplasty, THA	Device	Control Total Hip Replacement Device, Investigational Hard-on-Hard Total Hip Replacement Device

Primary outcome

Number of Participants With Device-Related Revisions
Time frame: 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
Time frame: 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.

9 secondary outcomes

Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only
Time frame: 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)
Time frame: Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 years
Radiographic Measures: Radiolucencies
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Radiographic Measures: Heterotopic Ossification
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Radiographic Measures: Subsidence
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Health Economic Outcomes: Surgical Blood Loss
Time frame: Intra-operative, up to 50 minutes
Health Economic Outcomes: Length of Hospital Stay
Time frame: Hospital admission to discharge
Health Economic Outcomes: Operative Time
Time frame: Intra-operative
Health Economic Outcomes: Re-Hospitalizations
Time frame: Up to 10 years

Results and safety

Results posted to the registry on 6 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational Hard-on-Hard Total Hip Replacement Device	20	16
Control Total Hip Replacement Device	6	4

Primary outcome: Number of Participants With Device-Related Revisions

Time frame: Postoperatively through 10 years. Count of participants. Unit: Participants

Measure	Investigational Hard-on-Hard Total Hip Replacement Device n = 20	Control Total Hip Replacement Device n = 6
Revision Required: Yes	1	0
Revision Required: No	19	6

Population analysed: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated.

Primary outcome: Metal Ion Concentration in Whole Blood

Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.. Mean (Standard Deviation). Unit: nanograms per milliliter (ng/ml)

Measure	Investigational Hard-on-Hard Total Hip Replacement Device n = 20	Control Total Hip Replacement Device n = 6
Cobalt (Co) Concentration in Whole Blood - 3 Months	0.2 (0.14)	0.3 (0.32)
Cobalt (Co) Concentration in Whole Blood - 6 Months	0.2 (0.09)	0.2 (0.08)
Cobalt (Co) Concentration in Whole Blood - 1 Year	0.2 (0.10)	0.2 (0.10)
Cobalt (Co) Concentration in Whole Blood - 2 Years	0.3 (0.30)	0.2 (0.12)
Cobalt (Co) Concentration in Whole Blood - 5 Years	0.1 (0.06)	0.1 (0.07)
Cobalt (Co) Concentration in Whole Blood - 7 Years	0.3 (0.17)	1.0 (1.56)
Cobalt (Co) Concentration in Whole Blood -10 Years	0.3 (0.12)	0.2 (0.06)
Chromium (Cr) Concentration in Whole Blood - 3 Months	0.5 (0.18)	0.5 (0.16)

Population analysed: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Surgery to 10-years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Hard-on-Hard Total Hip Replacement Device	9 of 20 (45%)	20 of 20 (100%)	2 of 20
Control Total Hip Replacement Device	3 of 6 (50%)	6 of 6 (100%)	1 of 6

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Baker principal investigator

Entabeni Hospital

Johannes de Beer principal investigator

Zuid Afrikaans Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ODH Hip System in people with Arthritis, Degenerative, run by Smith & Nephew, Inc. at 2 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Device-Related Revisions (time frame: Postoperatively through 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02154516.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.