NCT00722007 (PASNew) is a NA clinical trial of Cormet Hip Resurfacing in Osteoarthritis, sponsored by Corin.

Who is sponsoring NCT00722007?

NCT00722007 is sponsored by Corin.

What drugs are being tested in NCT00722007?

Interventions in NCT00722007: Cormet Hip Resurfacing.

What condition does NCT00722007 study?

NCT00722007 studies Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis.

Is NCT00722007 still recruiting?

NCT00722007 is currently completed. Last updated 2 July 2019.

Are results published for NCT00722007?

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

Last reviewed 2019-07-02 · How we verify

NCT00722007: PASNew

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

Cormet Post-PMA Study: New Enrollment

Completed NA Results posted Last updated 2 July 2019

What this trial tests

NA trial testing Cormet Hip Resurfacing in Osteoarthritis in 147 participants. Completed in 12 May 2014.

Timeline

24 April 2008

Primary endpoint
11 April 2014

12 May 2014

Quick facts

Lead sponsor	Corin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	147
Start date	24 April 2008
Primary completion	11 April 2014
Estimated completion	12 May 2014
Sites	6 locations across United States

Drugs / interventions tested

Cormet Hip Resurfacing

Conditions studied

Osteoarthritis — all drugs for Osteoarthritis →
Avascular Necrosis — all drugs for Avascular Necrosis →
Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Corin — full company profile →

Who can join

Eligibility, any sex, with Osteoarthritis or Avascular Necrosis. 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.

The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24 Primary · Month 24+

Composite Clinical Success (CCS) is based upon the following: There has been no revision, removal, or replacement of any device component on or prior to the exact 24 month anniversary (i.e., relative day 730); and Month 24 Harris Hip Total score (HHS) ≥ 80 points.

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	104

Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ Secondary · Month 24+

All unilateral and bilateral implants have been assessed using the following grading: Total HHS: Excellent (90-100); Good (80-89); Fair (70-79); Poor (\<70) Pain HHS: None; Slight; Mild; Moderate; Marked; Totally Disabled Function HHS: Normal (40-47); Mild Dysfunction (30=\<39); Moderate Dysfunction (20=\<29); Severe Dysfunction (10=\<19); Disabled (0=\<9)

Total HHS Excellent (90-100)

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	109

Total HHS Good (80-89)

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	10

Total HHS Fair (70-79)

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	6

Total HHS Poor (<70)

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	1

Total HHS missing

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	2

Pain HHS None

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	87

Pain HHS Slight

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	28

Pain HHS Mild

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	8

Survival Rate Using Kaplan-Meier Survival Curves Secondary · Month 24+

Kaplan-Meier survival curves were completed for all implants (unilateral \& bilateral) for Month 24

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	155

Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events Secondary · Month 24+

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	9

The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively Secondary · Month 24+

The following was assessed: Radiolucency Acetabular Component: I; II; III Radiolucency Femoral Component: Superior; Tip; Inferior Cup Migration and Tilt: Superior/Inferior Migration \> 4mm; Medial/Lateral Migration \> 4mm; Varus/Valgus Tilt \> 4 degrees Stem Migration and Tilt: Subsidence of Femoral Component \> 4mm and Stem tilting \> 4 degrees Other Assessments: Anteversion of the Head ≥ 5mm; Retroversion of the Head ≥ 5 mm; Hypertrophy in Any Zone; Resorption in Any Zone; Lysis in Any Zone; Osteolysis

Radiolucency Acetabular Component - I

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	1

Radiolucency Acetabular Component - II

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	1

Radiolucency Acetabular Component - III

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	1

Radiolucency Femoral Component - Superior

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	0

Radiolucency Femoral Component - Tip

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	0

Radiolucency Femoral Component - Inferior

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	0

Superior/Inferior Cup Migration > 4mm

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	0

Medial/Lateral Cup Migration > 4mm

Group	Value	95% CI
Cormet Hip Resurfacing Post-PMA Group	0

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cormet Hip Resurfacing Post-PMA Group

Serious: 33/147 (22%)

Deaths: 0/147

Serious adverse events (16 terms)

Reaction	System	Cormet Hip Resurfacing Pos…
Contralateral hip resurfacing	Surgical and medical procedures	—
Contralateral THR	Surgical and medical procedures	—
Femoral neck fracture	Surgical and medical procedures	—
Contralateral revision THR	Surgical and medical procedures	—
Deep joint infection	Infections and infestations	—
Heart valve replacement	Cardiac disorders	—
Myocardial infarction	Cardiac disorders	—
Inguinal hernia	Gastrointestinal disorders	—
Cellulitis	Infections and infestations	—
Meniscus tear	Injury, poisoning and procedural complications	—
Hip pseudotumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Acetabular loosening	Surgical and medical procedures	—
Contralateral revision TKR	Surgical and medical procedures	—
Contralateral TKA	Surgical and medical procedures	—
Femoral loosening	Surgical and medical procedures	—
Hip dislocation	Surgical and medical procedures	—

Other adverse events (15 terms — click to expand)

Reaction	System	Cormet Hip Resurfacing Pos…
Hip pain (operative side)	Musculoskeletal and connective tissue disorders	—
Knee pain	Musculoskeletal and connective tissue disorders	—
Hip pain (operative side)	Injury, poisoning and procedural complications	—
Contralateral hip pain	Musculoskeletal and connective tissue disorders	—
Contralateral OA	Musculoskeletal and connective tissue disorders	—
Hypertension	Cardiac disorders	—
Fibula fracture	Injury, poisoning and procedural complications	—
Hamstring detachment	Injury, poisoning and procedural complications	—
Meniscus tear	Injury, poisoning and procedural complications	—
Groin pain	Musculoskeletal and connective tissue disorders	—
Iliopsoas tendonitis	Musculoskeletal and connective tissue disorders	—
IT band friction syndrome	Musculoskeletal and connective tissue disorders	—
L5-S1 spondylolisthesis	Musculoskeletal and connective tissue disorders	—
Hip dislocation	Surgical and medical procedures	—
DVT	Vascular disorders	—

Most-reported serious reactions: Contralateral hip resurfacing, Contralateral THR, Femoral neck fracture, Contralateral revision THR, Deep joint infection, Heart valve replacement, Myocardial infarction, Inguinal hernia.

Data from ClinicalTrials.gov NCT00722007 adverse events section.

Sponsor's own description

The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.

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 Osteoarthritis

Currently open trials in the same condition.

NCT07404891 — Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis · NA · recruiting
NCT07118501 — A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System · recruiting
NCT06631638 — EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) · NA · recruiting
NCT07198750 — "Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis" · NA · recruiting
NCT07006714 — Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) · Phase 4 · active not recruiting

Other Corin trials

Trials by the same sponsor.

NCT06518993 — Observational Study to Collect Safety Data and PROMs on Primary THA · terminated
NCT04872855 — Observational Study to Evaluate Clinical Performance and Safety in Total Knee Arthroplasty · terminated
NCT03956381 — Accuracy of OPS™ Femoral Neck Resection Study · completed
NCT06203756 — Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty · NA · enrolling by invitation
NCT05211141 — Study to Evaluate Long Term Performance and Safety of the Knee Prosthesis (HLS KneeTec Deep Dish) · terminated

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 NCT00722007 (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 Corin
Last refreshed: 2 July 2019

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/NCT00722007.

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