Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.

Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.

This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Avascular Necrosis; Hip Osteoarthritis; Noninflammatory Degenerative Joint Disease; Correction of Functional Deformity
• Intervention / Treatment: Device: Taperloc Complete Microplasty stem; Device: Taperloc Complete Reduced Distal stem

Detailed Description

A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner.

All potential study subjects will be required to participate in the Informed Consent process.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Roosendaal, Netherlands
    • Bravis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
• Correction of functional deformity.

• Male or female

  -≥ 18 and ≤ 70 years of age

• Subjects willing to return for follow-up evaluations.
• Subjects able to read and understand Dutch language.

Exclusion Criteria:

• active Infection (or within 6 weeks after infection)
• Sepsis
• Osteomyelitis
• Uncooperative patient or patient with neurologic disorders who are incapable of following directions
• diagnosed Osteoporosis or Osteomalacia
• Metabolic disorders which may impair bone formation
• Distant foci of infections which may spread to the implant site
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• Vascular insufficiency, muscular atrophy or neuromuscular disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taperloc Complete Microplasty stem; Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.	Device: Taperloc Complete Microplasty stem; Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner; Other Names: Total hip arthroplasty
Active Comparator: Taperloc Complete Reduced Distal stem; Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.	Device: Taperloc Complete Reduced Distal stem; Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner; Other Names: Total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)	Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)	2 years postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty	Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation.	2 years postoperatively
Early Survival Assessed by Counting the Number of Implant Revisions	Assessed by counting the number of implant revisions	Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)	Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)	pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation	Assess radiographs for signs of stress shielding, radiolucency and stem alignment.	6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)	The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms.	2 years postoperatively
Clinical Performance Measured by Patient Based Outcome EQ5D	Each question in the EQ5D assessment can be answered in three ways, indicating no, moderate or extreme problems. Index scores are created with a weight for each dimension, ranging from 0 (health state equivalent to death) to 1 (perfect health). The EQ5D also includes a question about health status, ranging from 0 (worst health) to 100 (best health).	2 years postoperatively
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)	The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score.	pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)	The Forgotten Joint Score (FJS) is a questionnaire, which focuses on the awareness of having a joint prosthesis. The rationale of this questionnaire is that the ultimate goal in joint arthroplasty resulting in the greatest possible patient satisfaction is the ability to forget the artificial joint. The outcome is scored on a 0 to 100 scale, with a total score of 0 indicating the highest level of awareness of having a joint prosthesis.	6 weeks, 1 year and 2 years postoperatively

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Paola Vivoda, BSc, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2017
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): November 6, 2020

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Performance; Medical Device; Hip prosthesis; Total Hip Arthroplasty; Roentgen Stereophotogrammetric Analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases; Necrosis; Osteoarthritis, Hip
• Other Study ID Numbers: ORTHO.CR.GH60

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes