Clinical trial NCT00754520: A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty
Official title: A Multi-center Prospective Randomized Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic-on-metal and Metal-on-metal as Used in Cementless Primary Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.

Detailed description: The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.

Eligibility criteria: Inclusion Criteria:

* Patients presenting with osteoarthritis and suitable for primary Total Hip Replacement
* Patients preoperative Harris Hip Score \<= 70 points
* Patients aged over 18 and under 75
* Patients with limited co-morbidity - ASA I-III
* Patients with normal urea and electrolyte levels and creatinine levels
* Patients must be able to understand instructions and be willing to return for follow-up
* Patients willing to provide blood and urine samples for metal ion analysis at follow up

Exclusion Criteria:

* Patients preoperative Harris Hip Score \> 70 points
* Previous prosthetic hip surgery
* Patients with significant co-morbidity - ASA IV - V
* Dementia and inability to understand and follow instructions
* Neurological conditions affecting movement
* Existing metal implant or fixation device
* Pregnancy
* Presence of symptomatic arthritis in other lower limb joints

Primary outcomes:
measure: Composite Clinical Success (CCS) Rate as Defined in the Protocol
timeFrame: 2 years post-operatively
Secondary outcomes:
measure: Oxford Hip Score
timeFrame: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively
measure: Womac Score
timeFrame: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively
measure: Metal Ion Concentrations in Blood
timeFrame: 6 months post-operatively, 1, 2, 3 and 5 years post-operatively
measure: Survivorship
timeFrame: 10 years post-op
Other outcomes:
Locations:
city: Jyvaskyla
country: Finland
facility: Central Finland Central Hospital
city: Kotka
country: Finland
facility: Kymenlaakso Central Hospital
city: Basingstoke
country: United Kingdom
facility: North Hampshire Hospital
Study officials:
affiliation: North Hampshire Hospital
name: G. Stranks, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Finland Central Hospital
name: M Pesola
role: PRINCIPAL_INVESTIGATOR
affiliation: Kymenlaakso Central Hospital Kotka Finland
name: H Kauppinen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Higgins JE, Conn KS, Britton JM, Pesola M, Manninen M, Stranks GJ. Early Results of Our International, Multicenter, Multisurgeon, Double-Blinded, Prospective, Randomized, Controlled Trial Comparing Metal-on-Metal With Ceramic-on-Metal in Total Hip Arthroplasty. J Arthroplasty. 2020 Jan;35(1):193-197.e2. doi: 10.1016/j.arth.2019.08.002. Epub 2019 Aug 22.