NCT03272373 is a NA clinical trial of NexGen TM Monoblock Tibia in Osteoarthritis, sponsored by Zimmer Biomet.

Who is sponsoring NCT03272373?

NCT03272373 is sponsored by Zimmer Biomet.

What drugs are being tested in NCT03272373?

Interventions in NCT03272373: NexGen TM Monoblock Tibia, NexGen TM Modular Tibia.

What condition does NCT03272373 study?

NCT03272373 studies Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Collagen Disorders and/or Avascular Necrosis of the Femoral Condyle, Post-traumatic Loss of Joint Configuration, Moderate Valgus, Varus, or Flexion Deformities.

Is NCT03272373 still recruiting?

NCT03272373 is currently completed. Last updated 30 December 2024.

Are results published for NCT03272373?

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

Last reviewed 2024-12-30 · How we verify

NCT03272373

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

NexGen TM Tibia Clinical Outcomes Study

Completed NA Results posted Last updated 30 December 2024

What this trial tests

NA trial testing NexGen TM Monoblock Tibia in Osteoarthritis in 160 participants. Completed in 31 March 2023.

Timeline

3 October 2017

Primary endpoint
30 March 2023

31 March 2023

Quick facts

Lead sponsor	Zimmer Biomet
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	160
Start date	3 October 2017
Primary completion	30 March 2023
Estimated completion	31 March 2023
Sites	7 locations across United States

Drugs / interventions tested

NexGen TM Monoblock Tibia
NexGen TM Modular Tibia

Conditions studied

Osteoarthritis — all drugs for Osteoarthritis →
Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
Traumatic Arthritis — all drugs for Traumatic Arthritis →
Polyarthritis — all drugs for Polyarthritis →

Sponsor

Zimmer Biomet — full company profile →

Who can join

18 and older, any sex, with Osteoarthritis or Rheumatoid Arthritis. 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.

Radiograph Assessment of Progressive Tibial Radiolucencies Primary · 2 years

Progressive tibial radiolucency will be derived in accordance with the following definitions: Absent: No evidence of an increase in either radiolucency extent (number of zones involved) or measured width within a zone. Present: Presence of either: An increase in the number of zones with a measured tibial radiolucency, OR an increase in the measured tibial radiolucency width within a zone of \>0.5mm. Unable to assess: One or more of the component factors necessary to derive progressive tibial radiolucency is unavailable.

Group	Value	95% CI
NexGen TM Monoblock Tibia	82
NexGen TM Modular Tibia	55
NexGen TM Monoblock Tibia	0
NexGen TM Modular Tibia	0
NexGen TM Monoblock Tibia	1
NexGen TM Modular Tibia	0

Oxford Knee Score Secondary · 2 years

The Oxford Knee Score is a patient completed 12 question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The maximum score is 48 points (best) and the minimum score is 0 points (worst).

Group	Value	95% CI
NexGen TM Monoblock Tibia	64
NexGen TM Modular Tibia	47
NexGen TM Monoblock Tibia	25
NexGen TM Modular Tibia	5

Revision Rate Secondary · 2 years

Rate of the number of revisions for any reason

Group	Value	95% CI
NexGen TM Monoblock Tibia	108
NexGen TM Modular Tibia	63
NexGen TM Monoblock Tibia	2
NexGen TM Modular Tibia	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NexGen TM Monoblock Tibia

Serious: 10/104 (10%)

Deaths: 2/104

NexGen TM Modular Tibia

Serious: 7/56 (13%)

Deaths: 0/56

Serious adverse events (11 terms)

Reaction	System	NexGen TM Monoblock Tibia	NexGen TM Modular Tibia
Musculoskeletal (not study knee)	Musculoskeletal and connective tissue disorders	—	—
Contralateral Knee Replacement (UKA or TKA)	Musculoskeletal and connective tissue disorders	—	—
Other General Adverse Event	General disorders	—	—
Deep Wound Infection	Infections and infestations	—	—
Cardiovascular	Cardiac disorders	—	—
Endocrine	Endocrine disorders	—	—
Gastrointestinal	Gastrointestinal disorders	—	—
Genitourinary/Renal	Renal and urinary disorders	—	—
Neurological	Nervous system disorders	—	—
Pulmonary/Respiratory	Respiratory, thoracic and mediastinal disorders	—	—
Traumatic Injury (not study knee)	Injury, poisoning and procedural complications	—	—

Other adverse events (23 terms — click to expand)

Reaction	System	NexGen TM Monoblock Tibia	NexGen TM Modular Tibia
Musculoskeletal (not study knee)*	Musculoskeletal and connective tissue disorders	—	—
Pain (progressive/persistent)	Musculoskeletal and connective tissue disorders	—	—
Cardiovascular	Cardiac disorders	—	—
Contralateral Knee Replacement (UKA or TKA)	Surgical and medical procedures	—	—
Clicking/Popping/Crepitus/Grinding	Musculoskeletal and connective tissue disorders	—	—
Other General Adverse Event	General disorders	—	—
Vascular/DVT	Vascular disorders	—	—
Effusion/Swelling/Edema	Musculoskeletal and connective tissue disorders	—	—
Traumatic Injury (study knee)	Injury, poisoning and procedural complications	—	—
Infection (not study knee)	Infections and infestations	—	—
Neurological	Nervous system disorders	—	—
Oncological	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Pulmonary/Respiratory	Respiratory, thoracic and mediastinal disorders	—	—
Stiffness/Limited ROM (progressive/persistent)	Musculoskeletal and connective tissue disorders	—	—
Wound Dehiscence	Skin and subcutaneous tissue disorders	—	—
Cellulitis/Redness/Blistering	Skin and subcutaneous tissue disorders	—	—
Other Ipsilateral Knee Related Adverse Event	General disorders	—	—
Dermatological	Skin and subcutaneous tissue disorders	—	—
Endocrine	Endocrine disorders	—	—
Genitourinary/Renal	Renal and urinary disorders	—	—
Wound Drainage	Skin and subcutaneous tissue disorders	—	—
Baker's Cyst	Musculoskeletal and connective tissue disorders	—	—
Articular Surface Dislocation/Disassociation	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Musculoskeletal (not study knee), Contralateral Knee Replacement (UKA or TKA), Other General Adverse Event, Deep Wound Infection, Cardiovascular, Endocrine, Gastrointestinal, Genitourinary/Renal.

Data from ClinicalTrials.gov NCT03272373 adverse events section.

Sponsor's own description

The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.

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 Zimmer Biomet trials

Trials by the same sponsor.

NCT06287853 — Tapestry Rotator Cuff Repair PMCF · suspended
NCT06863428 — Mymobility Knee ROM · recruiting
NCT06920459 — Zimmer Biomet Shoulder Arthroplasty PMCF Study · recruiting
NCT07009912 — ROSA® Knee System V1.5 Pilot Study · NA · completed
NCT06615739 — Comprehensive SRS Regenerex Tissue Attachment · active not recruiting

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 NCT03272373 (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 Zimmer Biomet
Last refreshed: 30 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/NCT03272373.

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