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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409666
• Other study ID #: ORTHO.CR.GH60
• Status: Completed
• Phase: N/A
• Start date: May 12, 2017
• Est. completion date: November 6, 2020

Study information

• Verified date: June 2022
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis
• Correction of Functional Deformity
• Hip Osteoarthritis
• Joint Diseases
• Necrosis
• Noninflammatory Degenerative Joint Disease
• Osteoarthritis
• Osteoarthritis, Hip
• Rheumatoid Arthritis

Intervention

Device:
• Taperloc Complete Microplasty stem
Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
• Taperloc Complete Reduced Distal stem
Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner

Locations

Country	Name	City	State
Netherlands	Bravis	Roosendaal

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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