Clinical trial NCT02518269: A 3-Arm Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty
Official title: A Prospective 3-Arm Randomized Controlled Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthrosis
Pain
Arthritis
Keywords: hip
arthroplasty
G7
EchoBimetric
E1
ceramic
Arcom XL
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2015-08-07
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to compare three articulation options in terms of osteolysis, patient satisfaction, clinical and radiographic outcomes (Oxford Hip score (OHS) and Harris Hip score (HHS) and safety.

In addition, the purpose of the study is also to evaluate the safety and effectiveness of patients who received G7 Acetabular system in conjunction with Echo BiMetric stem in primary total hip arthroplasty.

Detailed description: DESIGN: Prospective 3 Arm Randomized controlled trial.

PURPOSE:To compare three commonly used contemporary bearings in Total Hip Arthroplasty (THA). In addition, to evaluate the safety and effectiveness of the G7 Cups and Echo BiMetric Stem in THA.

OUTCOME MEASURES: Osteolysis, clinical outcomes, patient satisfaction, intraoperative/surgical data, implant positioning, survivor ship, and adverse events.

POPULATION: 360 hips (240 will have CT scan for analysis of osteolysis).

ELIGIBILITY: Patients who meet inclusion and exclusion criteria defined in this protocol.

DURATION: All patients will be followed at 3 months, 1, 2, 5, 7 and 10 year postoperatively. Assuming the enrollment will be completed 18 months. The total study duration will be 11.5 years.

STUDY GROUPS/TREATMENTS

Group 1 - G7 Metal-on-Polyethylene (MoP) (Arcom XL) + Echo BiMetric Group 2 - G7 Metal-on-Polyethylene (MoP) (E1) + Echo BiMetric Group 3 - G7 Ceramic-on-Ceramic (CoC) + Echo BiMetric The study's primary efficacy endpoint will include the difference in osteolytic volume at 5 years postoperatively measured by Computertomografi (CT) scan.

Eligibility criteria: Inclusion Criteria:

Patient is 18 to 75 years of age, inclusive.

* Patients determined to be suitable for uncemented fixation by investigator
* Patient is skeletally mature.
* Patient qualifies for primary unilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:

  * Osteoarthritis (OA)
  * Developmental Dysplasia without subluxation
* Patient is willing and able to provide written informed consent.
* Patient is willing and able to cooperate in the required post-operative therapy.
* Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.

Exclusion Criteria:

The patient is:

* A prisoner
* Mentally incompetent or unable to understand what participation in the study entails
* A known alcohol or drug abuser
* Anticipated to be non-compliant.

  * The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
  * The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
  * The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
  * The patient is known to be pregnant.
  * The patient is unwilling or unable to give informed consent, or to comply with the follow-up program.
  * The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.

The patient has had previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.

* The patient has insufficient bone stock to fix the component. Insufficient bone stock exists (ex: Dorr type C) in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation.
* Estimated cup size smaller than 48 or stem size smaller than 7
* The patient has known local bone tumors in the operative hip.

Primary outcomes:
measure: Difference in osteolytic volume at 5 years postoperatively measured by CT scan.
timeFrame: 5 years
Secondary outcomes:
measure: Hip specific clinical outcome in patients who received the one of the above mentioned combinations of total hip systems.
timeFrame: 3 months, 1,2,5,7 and 10 year follow up
measure: Implant positioning
timeFrame: Immediately postoperative,1,2,5,7 and 10 year follow up
measure: Subjective satisfaction
timeFrame: 3 months, 1,2,5,7 and 10 year follow up
measure: Safety and survivorship
timeFrame: Continously throughout the study until 10 years FU
measure: Squeaking evaluation
timeFrame: 3 months, 1,2,5,7,10 years
measure: Pain Assessment
timeFrame: 3 months, 1,2,5,7,10 years
measure: Health related quality of life
timeFrame: 3 months, 1,2,5,7,10 years
measure: Physical activity level
timeFrame: 3 months, 1,2,5,7,10 years
measure: Hip specific clinical patient outcome measure
timeFrame: 3 months, 1,2,5,7,10 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Hvidovre hospital
city: Jämsä
country: Finland
facility: Jokilaakson Terveys Oy
city: Turku
country: Finland
facility: Turku university hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Anders Troelsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska University Hospital
name: Henrik Malchau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jokilaakson Terveys Oy
name: Ville Remes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: