NCT02154516 is a NA clinical trial of ODH Hip System in Arthritis, Degenerative, sponsored by Smith & Nephew, Inc..

Who is sponsoring NCT02154516?

NCT02154516 is sponsored by Smith & Nephew, Inc..

What drugs are being tested in NCT02154516?

Interventions in NCT02154516: ODH Hip System.

What condition does NCT02154516 study?

NCT02154516 studies Arthritis, Degenerative.

Is NCT02154516 still recruiting?

NCT02154516 is currently completed. Last updated 6 December 2024.

Are results published for NCT02154516?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-12-06 · How we verify

NCT02154516

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 6 December 2024

What this trial tests

NA trial testing ODH Hip System in Arthritis, Degenerative in 26 participants. Completed in 18 October 2022.

Timeline

4 November 2011

Primary endpoint
18 October 2022

18 October 2022

Quick facts

Lead sponsor	Smith & Nephew, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	4 November 2011
Primary completion	18 October 2022
Estimated completion	18 October 2022
Sites	2 locations across South Africa

Drugs / interventions tested

ODH Hip System

Conditions studied

Arthritis, Degenerative — all drugs for Arthritis, Degenerative →

Sponsor

Smith & Nephew, Inc. — full company profile →

Who can join

21 and older, any sex, with Arthritis, Degenerative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Device-Related Revisions Primary · Postoperatively through 10 years

Device related revisions reported by the number of participants with a revision required (Yes/No).

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	1
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	19
Control Total Hip Replacement Device	6

Metal Ion Concentration in Whole Blood Primary · 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.

Cobalt (Co) Concentration in Whole Blood - 3 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	0.2	± 0.14
Control Total Hip Replacement Device	0.3	± 0.32

Cobalt (Co) Concentration in Whole Blood - 6 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	0.2	± 0.09
Control Total Hip Replacement Device	0.2	± 0.08

Cobalt (Co) Concentration in Whole Blood - 1 Year

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	0.2	± 0.10
Control Total Hip Replacement Device	0.2	± 0.10

Cobalt (Co) Concentration in Whole Blood - 2 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	0.3	± 0.30
Control Total Hip Replacement Device	0.2	± 0.12

Cobalt (Co) Concentration in Whole Blood - 5 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	0.1	± 0.06
Control Total Hip Replacement Device	0.1	± 0.07

Cobalt (Co) Concentration in Whole Blood - 7 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	0.3	± 0.17
Control Total Hip Replacement Device	1.0	± 1.56

Cobalt (Co) Concentration in Whole Blood -10 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	0.3	± 0.12
Control Total Hip Replacement Device	0.2	± 0.06

Chromium (Cr) Concentration in Whole Blood - 3 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	0.5	± 0.18
Control Total Hip Replacement Device	0.5	± 0.16

Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only Secondary · 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.

Preoperative

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	51.0	± 9.48

3 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	85.6	± 11.28

6 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	92.6	± 9.77

1 Year

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	94.7	± 9.79

2 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	95.2	± 10.21

5 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	92.9	± 14.44

7 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	94.9	± 12.60

10 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	97.1	± 9.35

Hip Disability and Osteoarthritis Outcome Scores (HOOS) Secondary · 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.

Preoperative

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	44.9	± 19.86

3 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	83.8	± 18.84

6 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	85.8	± 21.08

1 Year

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	91.8	± 14.53

2 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	92.9	± 14.07

5 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	85.6	± 26.91

7 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	88.8	± 22.95

10 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	88.4	± 22.87

Radiographic Measures: Radiolucencies Secondary · 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)

Radiolucent Line - 3 months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	17
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	3
Control Total Hip Replacement Device	0

Osteolysis - 3 months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	17
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	3
Control Total Hip Replacement Device	0

Radiolucent Line - 6 months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	19
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Osteolysis - 6 months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	18
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	1
Control Total Hip Replacement Device	0

Radiolucent Line - 1 Year

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	15
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	4
Control Total Hip Replacement Device	0

Osteolysis - 1 Year

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	13
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	6
Control Total Hip Replacement Device	0

Radiolucent Line - 2 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	17
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	2
Control Total Hip Replacement Device	0

Osteolysis - 2 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	17
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	2
Control Total Hip Replacement Device	0

Radiographic Measures: Heterotopic Ossification Secondary · 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)

Heterotopic Ossification - 3 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	18
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	2
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Heterotopic Ossification - 6 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	15
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	3
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	1
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Heterotopic Ossification - 1 Year

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	14
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	4
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	1
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Heterotopic Ossification - 2 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	18
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	1
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Heterotopic Ossification - 5 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	16
Control Total Hip Replacement Device	4
Investigational Hard-on-Hard Total Hip Replacement Device	1
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	1
Control Total Hip Replacement Device	1
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Heterotopic Ossification - 7 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	14
Control Total Hip Replacement Device	2
Investigational Hard-on-Hard Total Hip Replacement Device	2
Control Total Hip Replacement Device	2
Investigational Hard-on-Hard Total Hip Replacement Device	1
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Heterotopic Ossification - 10 Years

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	13
Control Total Hip Replacement Device	2
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	2
Investigational Hard-on-Hard Total Hip Replacement Device	1
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Radiographic Measures: Subsidence Secondary · 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

Acetabular Cup Subsidence - 3 months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	20
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Stem Subsidence - 3 months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	20
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Evidence of cortical thickening - 3 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	20
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Acetabular component fail - 3 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	20
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Femoral component fail - 3 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	20
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Other - 3 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	20
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Acetabular Cup Subsidence - 6 months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	19
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Stem Subsidence - 6 Months

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	19
Control Total Hip Replacement Device	0
Investigational Hard-on-Hard Total Hip Replacement Device	0
Control Total Hip Replacement Device	0

Health Economic Outcomes: Surgical Blood Loss Secondary · Intra-operative, up to 50 minutes

Blood loss during surgery measured in milliliters (ml) of blood

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	324	± 218.6
Control Total Hip Replacement Device	365	± 164.2

Health Economic Outcomes: Operative Time Secondary · 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

Group	Value	95% CI
Investigational Hard-on-Hard Total Hip Replacement Device	50.0	± 14.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Surgery to 10-years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Investigational Hard-on-Hard Total Hip Replacement Device

Serious: 9/20 (45%)

Deaths: 2/20

Control Total Hip Replacement Device

Serious: 3/6 (50%)

Deaths: 1/6

Serious adverse events (25 terms)

Reaction	System	Investigational Hard-on-Ha…	Control Total Hip Replacem…
Contralateral hip replacement	Musculoskeletal and connective tissue disorders	—	—
Kidney Stones	Renal and urinary disorders	—	—
Uncontrolled Hypertension	Cardiac disorders	—	—
Death from unknown cause	General disorders	—	—
left shoulder Rotator cuff tear	Musculoskeletal and connective tissue disorders	—	—
Irritable Bowel Syndrome	Gastrointestinal disorders	—	—
Depression and psychosomatic disorder	Psychiatric disorders	—	—
Gastroscopy and biopsy	Gastrointestinal disorders	—	—
Worsening of prior muscle spasm and pain in study hip	Musculoskeletal and connective tissue disorders	—	—
Urinary retention	Renal and urinary disorders	—	—
Death	General disorders	—	—
Bilateral inguinal hernia	Musculoskeletal and connective tissue disorders	—	—
Anterior right hip dislocation	Musculoskeletal and connective tissue disorders	—	—
Osteoarthritis left ankle	Musculoskeletal and connective tissue disorders	—	—
Osteoarthritis effusion left knee	Musculoskeletal and connective tissue disorders	—	—
Right shoulder rotator cuff tear	Musculoskeletal and connective tissue disorders	—	—
Loosening of implant stem	Musculoskeletal and connective tissue disorders	—	—
Fall onto right hip (replacement hip)	Musculoskeletal and connective tissue disorders	—	—
Breast augmentation surgery	Surgical and medical procedures	—	—
Surgery left foot	Surgical and medical procedures	—	—
Sacroilliac joint pain	Musculoskeletal and connective tissue disorders	—	—
Sacroilliac joint pain treatment	Surgical and medical procedures	—	—
Haemorrhoids resulting in surgery	Vascular disorders	—	—
Death	Cardiac disorders	—	—
Hysterectomy	Reproductive system and breast disorders	—	—

Other adverse events (51 terms — click to expand)

Reaction	System	Investigational Hard-on-Ha…	Control Total Hip Replacem…
Increased Nickel Levels	Blood and lymphatic system disorders	—	—
Increased Cobalt Levels	Blood and lymphatic system disorders	—	—
Hypertension	Cardiac disorders	—	—
Increased Vanadium Levels	Blood and lymphatic system disorders	—	—
Hip noise	Musculoskeletal and connective tissue disorders	—	—
Increased Niobium Levels	Blood and lymphatic system disorders	—	—
Increased Titanium Levels	Blood and lymphatic system disorders	—	—
Increased Chromium Levels	Blood and lymphatic system disorders	—	—
Greater trochanter bursitis R hip	Musculoskeletal and connective tissue disorders	—	—
Osteoarthritis left hip	Musculoskeletal and connective tissue disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Rash at operative site	Skin and subcutaneous tissue disorders	—	—
Intermittent back pain	Musculoskeletal and connective tissue disorders	—	—
Pain and noise in right hip	Musculoskeletal and connective tissue disorders	—	—
Benign prostate hyperplasia	Reproductive system and breast disorders	—	—
Hypotension	Cardiac disorders	—	—
Rash on back	Skin and subcutaneous tissue disorders	—	—
Gout	Musculoskeletal and connective tissue disorders	—	—
Fall	Musculoskeletal and connective tissue disorders	—	—
Chest pain and shortness of breath	Respiratory, thoracic and mediastinal disorders	—	—
Right knee pain	Musculoskeletal and connective tissue disorders	—	—
Bursitis	Musculoskeletal and connective tissue disorders	—	—
Femoral nerve impingement right leg	Nervous system disorders	—	—
Low oxygen levels	Respiratory, thoracic and mediastinal disorders	—	—
Sacroilliac pain	Musculoskeletal and connective tissue disorders	—	—
Left tennis elbow	Musculoskeletal and connective tissue disorders	—	—
Surgery-left foot	Musculoskeletal and connective tissue disorders	—	—
Diabetes - new	Endocrine disorders	—	—
Polyuria and hematuria	Renal and urinary disorders	—	—
Vomitting	Gastrointestinal disorders	—	—
Kidney stones	Renal and urinary disorders	—	—
Pain in operative hip	Musculoskeletal and connective tissue disorders	—	—
Muscle spasm	Musculoskeletal and connective tissue disorders	—	—
Rash - jugular	Skin and subcutaneous tissue disorders	—	—
Peripheral neuropathy	Nervous system disorders	—	—
Urinary Tract Infection	Renal and urinary disorders	—	—
Surgical site reaction	Infections and infestations	—	—
Perineal nerve weakness left foot	Nervous system disorders	—	—
rash - left foot	Skin and subcutaneous tissue disorders	—	—
Swelling below left fibular head	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Contralateral hip replacement, Kidney Stones, Uncontrolled Hypertension, Death from unknown cause, left shoulder Rotator cuff tear, Irritable Bowel Syndrome, Depression and psychosomatic disorder, Gastroscopy and biopsy.

Data from ClinicalTrials.gov NCT02154516 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02154516 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Smith & Nephew, Inc.
Last refreshed: 6 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02154516.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing