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CompletedNCT03409666Updated Jul 14, 2022Results posted

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

An interventional study of Taperloc Complete Microplasty stem and Taperloc Complete Reduced Distal stem in Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease and Avascular Necrosis, sponsored by Zimmer Biomet. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-14.

Sponsored by Zimmer Biomet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceTaperloc Complete Microplasty stem

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

    Also known as: Total hip arthroplasty

  • DeviceTaperloc Complete Reduced Distal stem

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

    Also known as: Total hip arthroplasty

05

What researchers measure

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)

    Time frame: 2 years postoperatively

Secondary outcomes

  1. 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.

    Time frame: 2 years postoperatively

  2. Early Survival Assessed by Counting the Number of Implant Revisions

    Assessed by counting the number of implant revisions

    Time frame: Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively

  3. 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)

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

  4. Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation

    Assess radiographs for signs of stress shielding, radiolucency and stem alignment.

    Time frame: 6 weeks, 1 year and 2 years postoperatively

  5. 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.

    Time frame: 2 years postoperatively

  6. 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).

    Time frame: 2 years postoperatively

  7. 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.

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

  8. 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.

    Time frame: 6 weeks, 1 year and 2 years postoperatively

06

Results

Posted Jul 14, 2022
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.

Participant flow

Participant flow — Overall Study
MilestoneTaperloc Complete Microplasty StemTaperloc Complete Reduced Distal Stem
Started2525
Completed2521
Not completed04
Withdrew: Physician decision01
Withdrew: Protocol violation03

Outcome measures

PrimaryStability 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)

Time frame:
2 years postoperatively
Reported as:
Mean · mm
Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)
mmTaperloc Complete Microplasty StemTaperloc Complete Reduced Distal Stem
Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)3.15 ± 2.403.90 ± 4.17
SecondaryDifference 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.

Time frame:
2 years postoperatively
Reported as:
Number · participants
Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty
participantsTaperloc Complete Microplasty StemTaperloc Complete Reduced Distal Stem
Stem malalignment00
Incorrect sizing00
Subsidence26
SecondaryEarly Survival Assessed by Counting the Number of Implant Revisions

Assessed by counting the number of implant revisions

Time frame:
Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively
Reported as:
Number · implant revisions
Early Survival Assessed by Counting the Number of Implant Revisions
implant revisionsTaperloc Complete Microplasty StemTaperloc Complete Reduced Distal Stem
Early Survival Assessed by Counting the Number of Implant Revisions00
SecondaryClinical 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)

Time frame:
pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Reported as:
Mean · scores on a scale
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)
scores on a scaleTaperloc Complete Microplasty StemTaperloc Complete Reduced Distal Stem
pre-op63.9 ± 7.765.1 ± 13.9
6 week79.9 ± 11.482.4 ± 8.8
1 year96.7 ± 4.695.7 ± 5.9
2 year98.3 ± 3.197.6 ± 4.9
SecondaryClinical Performance Measured by Clinician Based Outcome Radiological Evaluation

Assess radiographs for signs of stress shielding, radiolucency and stem alignment.

Time frame:
6 weeks, 1 year and 2 years postoperatively
Reported as:
Count of participants · Participants
Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation
ParticipantsTaperloc Complete Microplasty StemTaperloc Complete Reduced Distal Stem
Stress shielding00
Radiolucency00
stem alignment (between <5 valgus and <5 varus)2521
SecondaryClinical 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.

Time frame:
2 years postoperatively
Reported as:
Mean · scores on a scale
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
scores on a scaleTaperloc Complete Microplasty StemTaperloc Complete Reduced Distal Stem
Pain94.2 ± 10.592 ± 9.2
Symptoms89.8 ± 1285.5 ± 13.3
Activity limitations daily living92.7 ± 11.490.8 ± 10.1
Sport/Recreation80.7 ± 24.179.6 ± 20.2
Quality of life89.7 ± 16.884.4 ± 17
SecondaryClinical 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).

Time frame:
2 years postoperatively
Reported as:
Mean · score on a scale
Clinical Performance Measured by Patient Based Outcome EQ5D
score on a scaleTaperloc Complete Microplasty StemTaperloc Complete Reduced Distal Stem
EQ-5D0.9 ± 0.10.9 ± 0.1
Health status81.0 ± 12.381.0 ± 15.6
SecondaryClinical 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.

Time frame:
pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Reported as:
Mean · scores on a scale
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)
scores on a scaleTaperloc Complete Microplasty StemTaperloc Complete Reduced Distal Stem
pre-op26.1 ± 7.625.6 ± 8.5
6 week38.3 ± 6.737.5 ± 4.8
1 year44.6 ± 3.443.1 ± 4.1
2 year45.7 ± 3.844.9 ± 3.6
SecondaryClinical 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.

Time frame:
6 weeks, 1 year and 2 years postoperatively
Reported as:
Mean · score on a scale
Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)
score on a scaleTaperloc Complete Microplasty StemTaperloc Complete Reduced Distal Stem
6 week47.8 ± 3043.2 ± 26.1
1 year69.9 ± 29.261.7 ± 29.6
2 year72.3 ± 30.580.3 ± 26.5

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Taperloc Complete Microplasty Stem0/25 (0%)2/25 (8%)2/25 (8%)
Taperloc Complete Reduced Distal Stem0/21 (0%)0/21 (0%)9/21 (42.9%)
Most frequent serious events
Most frequent serious events
EventTaperloc Complete Microplasty StemTaperloc Complete Reduced Distal Stem
FeverGeneral disorders1/250/21
hypotensionCardiac disorders1/250/21
Most frequent other events
Most frequent other events
EventTaperloc Complete Microplasty StemTaperloc Complete Reduced Distal Stem
Stem SubsidenceMusculoskeletal and connective tissue disorders2/256/21
Pedestal SignMusculoskeletal and connective tissue disorders0/252/21
Periarticular OssificationMusculoskeletal and connective tissue disorders0/251/21

Baseline characteristics

These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).

Age, Continuous
Age, Continuous(years)Taperloc Complete Microplasty StemTaperloc Complete Reduced Distal StemTotal
Mean63.6 ± 6.363.9 ± 6.563.7 ± 6.4
Sex: Female, Male
Sex: Female, Male(Participants)Taperloc Complete Microplasty StemTaperloc Complete Reduced Distal StemTotal
Female201535
Male5611
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Taperloc Complete Microplasty StemTaperloc Complete Reduced Distal StemTotal
Count of participants——0
07

Study locations

1 site
  • Bravis
    Roosendaal, Netherlands
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 1, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03409666
Lead sponsor
Zimmer Biomet
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
May 12, 2017
Primary completion
Nov 6, 2020
Completion
Nov 6, 2020
Results posted
Jul 14, 2022
Last update
Jul 14, 2022

Study contacts

Paola Vivoda, BSc
study director · Zimmer Biomet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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