A 3-Arm Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty

Pain Clinical Trial

Official title:

A Prospective 3-Arm Randomized Controlled Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02518269
• Other study ID #: ORTHO.CR.GH33
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 4, 2015
• Est. completion date: November 30, 2030

Study information

• Verified date: March 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: November 30, 2030
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Osteoarthritis
• Osteoarthrosis
• Pain

Intervention

Procedure:
• Hip Arthroplasty
Hip Arthroplasty comparing 3 different bearings.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Hvidovre hospital	Copenhagen
Finland	Jokilaakson Terveys Oy	Jämsä
Finland	Turku university hospital	Turku
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Denmark,  Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in osteolytic volume at 5 years postoperatively measured by CT scan.	CT scan will be performed on 240 of the 360 patients post operatively and at 5 years follow up	5 years
Secondary	Hip specific clinical outcome in patients who received the one of the above mentioned combinations of total hip systems.	Oxford Hip score (OHS) will be collected from all the patients preoperative and at all follow up visits.	3 months, 1,2,5,7 and 10 year follow up
Secondary	Implant positioning	Implant positioning will be measured using Martell method .	Immediately postoperative,1,2,5,7 and 10 year follow up
Secondary	Subjective satisfaction	Subjective satisfaction will be collected using Numerical Rating Scale (NRS) and will be collected preoperative and at all follow ups.	3 months, 1,2,5,7 and 10 year follow up
Secondary	Safety and survivorship	Adverse Events will be reported including revisions at any post-operative time points	Continously throughout the study until 10 years FU
Secondary	Squeaking evaluation	Evaluation of noise from the hip will be made at all follow up visits by a noise assessment form	3 months, 1,2,5,7,10 years
Secondary	Pain Assessment	Pain will be collected using Numerical Rating Scale (NRS) and will be collected preoperative and at all follow ups.	3 months, 1,2,5,7,10 years
Secondary	Health related quality of life	EQ5D (Health related quality of life questionnaire from Euro Qol) will be collected from all the patients preoperative and at all follow up visits.	3 months, 1,2,5,7,10 years
Secondary	Physical activity level	UCLA (University California Los Angeles activity questionnaire) will be collected from all the patients preoperative and at all follow up visits.	3 months, 1,2,5,7,10 years
Secondary	Hip specific clinical patient outcome measure	Harris Hip score (HHS)will be collected from all the patients preoperative and at all follow up visits.	3 months, 1,2,5,7,10 years