Who is sponsoring NCT00561600?

NCT00561600 is sponsored by DePuy Orthopaedics.

What drugs are being tested in NCT00561600?

Interventions in NCT00561600: ASR™-XL Modular Acetabular Cup System, Pinnacle™ acetabular shell.

What condition does NCT00561600 study?

NCT00561600 studies Non-inflammatory Degenerative Joint Disease.

Is NCT00561600 still recruiting?

NCT00561600 is currently completed. Last updated 9 August 2017.

Are results published for NCT00561600?

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

Last reviewed 2017-08-09 · How we verify

NCT00561600: ASR

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

Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System

Completed NA Results posted Last updated 9 August 2017

What this trial tests

NA trial testing ASR™-XL Modular Acetabular Cup System in Non-inflammatory Degenerative Joint Disease in 265 participants. Completed in 1 January 2012.

Timeline

1 November 2006

Primary endpoint
1 January 2012

1 January 2012

Quick facts

Lead sponsor	DePuy Orthopaedics
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	265
Start date	1 November 2006
Primary completion	1 January 2012
Estimated completion	1 January 2012
Sites	8 locations across United States

Drugs / interventions tested

ASR™-XL Modular Acetabular Cup System
Pinnacle™ acetabular shell

Conditions studied

Non-inflammatory Degenerative Joint Disease — all drugs for Non-inflammatory Degenerative Joint Disease →

Sponsor

DePuy Orthopaedics — full company profile →

Who can join

Adults 20 to 75, any sex, with Non-inflammatory Degenerative Joint Disease. 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.

Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes Primary · 24-month interval.

"Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score =\> 80 at 24 months"

Group	Value	95% CI
ASR XL Acetabular Cup System	82
Pinnacle Acetabular Cup System	92

T-Test of Harris Hip Total Score Means at 24 Months Secondary · 24 months

T-Test of Harris Hip total score means at 24 months

Group	Value	95% CI
ASR XL Acetabular Cup System	94.8	± 9.4
Pinnacle Acetabular Cup System	96.4	± 6.4

Harris Hip Pain Sub Score at 24 Months Secondary · 24 months

Mean Harris Hip Pain sub score

Group	Value	95% CI
ASR XL Acetabular Cup System	41.5	± 6.0
Pinnacle Acetabular Cup System	42.7	± 3.3

Harris Hip Function Score at 24 Months Secondary · 24 months

Mean Harris Hip Function sub score at 24 months

Group	Value	95% CI
ASR XL Acetabular Cup System	31.4	± 3.6
Pinnacle Acetabular Cup System	31.6	± 3.7

Analysis of Metal Ion Release - Serum Cobalt Secondary · Pre-operative

Serum Cobalt

Group	Value	95% CI
ASR XL Acetabular Cup System	0.10	0.07 – 0.18
Pinnacle Acetabular Cup System	0.10	0.06 – 0.40

Analysis of Metal Ion Release - Serum Chromium Secondary · pre-operative

Serum Chromium

Group	Value	95% CI
ASR XL Acetabular Cup System	0.12	0.07 – 1.30
Pinnacle Acetabular Cup System	0.12	0.07 – 2.73

Analysis of Metal Ion Release - Erythrocyte Cobalt Secondary · pre-operative

Erythrocyte cobalt

Group	Value	95% CI
ASR XL Acetabular Cup System	0.07	0.05 – 1.26
Pinnacle Acetabular Cup System	0.08	0.04 – 0.20

Analysis of Metal Ion Release - Erythrocyte Chromium Secondary · Pre-operative

Erythrocyte Chromium

Group	Value	95% CI
ASR XL Acetabular Cup System	0.55	0.20 – 59.45
Pinnacle Acetabular Cup System	0.62	0.15 – 2.23

Analysis of Metal Ion Release - Serum Cobalt Secondary · 4 months post-operative

Serum Cobalt

Group	Value	95% CI
ASR XL Acetabular Cup System	1.39	0.06 – 10.52
Pinnacle Acetabular Cup System	0.51	0.22 – 2.14

Analysis of Metal Ion Release - Serum Chromium Secondary · 4 months post operative

Serum Chromium

Group	Value	95% CI
ASR XL Acetabular Cup System	1.38	0.17 – 7.67
Pinnacle Acetabular Cup System	0.72	0.25 – 2.48

Analysis of Metal Ion Release - Erythrocyte Cobalt Secondary · 4 months post-operative

Erythrocyte Cobalt

Group	Value	95% CI
ASR XL Acetabular Cup System	0.85	0.06 – 8.41
Pinnacle Acetabular Cup System	0.26	0.17 – 0.92

Analysis of Metal Ion Release - Erythrocyte Chromium Secondary · 4 months post-operative

Erythrocyte Chromium

Group	Value	95% CI
ASR XL Acetabular Cup System	0.45	0.24 – 11.53
Pinnacle Acetabular Cup System	0.50	0.15 – 2.59

Adverse events — posted to ClinicalTrials.gov

Time frame: AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ASR XL Acetabular Cup System

Serious: 0

Deaths: —

Pinnacle Acetabular Cup System

Serious: 0

Deaths: —

Other adverse events (101 terms — click to expand)

Reaction	System	ASR XL Acetabular Cup System	Pinnacle Acetabular Cup Sy…
Bursitis	Musculoskeletal and connective tissue disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—
Device component issue	General disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Medical device site reaction	General disorders	—	—
Groin pain	Musculoskeletal and connective tissue disorders	—	—
Hip arthroplasty	Surgical and medical procedures	—	—
Pain	General disorders	—	—
Wound complication	Injury, poisoning and procedural complications	—	—
Blood heavy metal increased	Investigations	—	—
Atrial fibrillation	Cardiac disorders	—	—
Infection	Infections and infestations	—	—
Fracture	Injury, poisoning and procedural complications	—	—
Laceration	Injury, poisoning and procedural complications	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Myocardial infarction	Cardiac disorders	—	—
Iliotibial band syndrome	Injury, poisoning and procedural complications	—	—
Meniscus injury	Injury, poisoning and procedural complications	—	—
Muscle strain	Injury, poisoning and procedural complications	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Tendonitis	Musculoskeletal and connective tissue disorders	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Paresthesia	Nervous system disorders	—	—
Sciatica	Nervous system disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Knee arthroplasty	Surgical and medical procedures	—	—
Hypotension	Vascular disorders	—	—
Atrial flutter	Cardiac disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Coronary artery occlusion	Cardiac disorders	—	—
Sinus tachycardia	Cardiac disorders	—	—
Tachycardia	Cardiac disorders	—	—
Hip dysplasia	Congenital, familial and genetic disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Colitis	Gastrointestinal disorders	—	—
Ileus	Gastrointestinal disorders	—	—
Pancreatitis	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—

Data from ClinicalTrials.gov NCT00561600 adverse events section.

Sponsor's own description

The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.

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:

Other recruiting trials for Non-inflammatory Degenerative Joint Disease

Currently open trials in the same condition.

NCT03885622 — Safety and Efficacy of the ANTHEM™ CR Total Knee System · active not recruiting

Other DePuy Orthopaedics trials

Trials by the same sponsor.

NCT06631638 — EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) · NA · recruiting
NCT06323980 — INHANCE Stemless Reverse Shoulder IDE · NA · recruiting
NCT05357664 — PINNACLE® DM RSA Study · NA · terminated
NCT04630262 — ATTUNE Cementless FB Tibial Base Clinical Study · NA · terminated
NCT04730271 — Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee A · NA · completed

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 NCT00561600 (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 DePuy Orthopaedics
Last refreshed: 9 August 2017

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/NCT00561600.

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