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

NCT03409666 | Completed Results FDA Device

• 1 other identifier: ORTHO.CR.GH60
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Osteoarthritis; Noninflammatory Degenerative Joint Disease; Avascular Necrosis; Correction of Functional Deformity; Rheumatoid Arthritis

Keywords

Total Hip Arthroplasty; Medical Device; Performance; Safety; Hip prosthesis; Roentgen Stereophotogrammetric Analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty

  2 years postoperatively

• Early Survival 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)

  pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively

• Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation

  6 weeks, 1 year and 2 years postoperatively

• Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)

  2 years postoperatively

Study Arms (2)

Taperloc Complete Microplasty stem

EXPERIMENTAL

Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.

Device: Taperloc Complete Microplasty stem

Taperloc Complete Reduced Distal stem

ACTIVE COMPARATOR

Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.

Device: Taperloc Complete Reduced Distal stem

Interventions

Taperloc Complete Microplasty stem DEVICE

Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner

Also known as: Total hip arthroplasty

Taperloc Complete Microplasty stem

Taperloc Complete Reduced Distal stem DEVICE

Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner

Also known as: Total hip arthroplasty

Taperloc Complete Reduced Distal stem

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Bravis

Roosendaal, Netherlands

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteonecrosis; Arthritis, Rheumatoid

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and Caveats

A limitation of the study was that 14 patients had to be excluded for RSA analysis due to insufficient bone markers or not meeting other criteria to perform an accurate RSA migration calculation. However, as Valstar et al. (2005) stated that at least 15-25 patients are needed per group, we believe that the results of this study are still valuable.

Results Point of Contact

• Title: Lisette Smid
• Organization: Zimmer Biomet

lisette.smid@zimmerbiomet.com

+31 62 395 6378

Study Officials

• Paola Vivoda, BSc

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 assignment of treatment

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 24, 2018
• Study Start: May 12, 2017
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: July 14, 2022
• Results First Posted: July 14, 2022

Record last verified: 2022-06

Locations

NL (1)