The Viability of Short Stems in Total Hip Arthroplasty

NCT02577822 | Completed Results FDA Device

• 1 other identifier: STU00082654
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the viability of short femoral stems as an alternative to standard-length stems in total hip arthroplasty.

Conditions

Osteoarthritis of Hip

Outcome Measures

Primary Outcomes (5)

• Mean VR-12 Mental Composite Score Through 2 Years Post Operative

  Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Mental Composite Score (MCS) range from 5.2 to 76.3 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved mental wellness/function as reported by patients.

  Assesed pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

• Mean VR-12 Physical Composite Score Through 2 Years Post Operative

  Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Physical Composite Score (PCS) range from 6.3 to 71.8 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved mental wellness/function as reported by patients.

  Assessed pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

• PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative

  Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Behavior domain higher scores indicate more frequent and severe incidence of pain during daily activities

  Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

• PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative

  Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Physical Function domain higher scores indicated improved physical function as reported by the patient

  Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

• PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative

  Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Interference domain higher scores indicated greater impact on patient's ability to perform daily activities and social function

  Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

Secondary Outcomes (1)

• EBRA (Ein-Bild-Roentgen-Analyse) Femoral Component Analysis (EBRA-FCA) of Implant Subsidence Through 2 Years Post Operative

  Assessed 6 weeks post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

Study Arms (2)

Short Stem Group

OTHER

Short femoral stem

Device: Taperloc short length stem

Long Stem Group

OTHER

standard-length stem

Device: Taperloc standard length stem

Interventions

Taperloc standard length stem DEVICE

Long Stem Group

Taperloc short length stem DEVICE

Short Stem Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must require a total hip arthroplasty.
• Ages 18-85 years, regardless of gender, ethnicity, or pathology

You may not qualify if:

• This study excludes any populations at risk.
• Minors, as well as any persons unable to consent, will not be eligible.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine Department of Orthopaedic Surgery

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: David Manning, MD
• Organization: Northwestern University

david.manning@nm.org

312-695-6800

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 16, 2015
• Study Start: October 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: July 1, 2019
• Last Updated: January 9, 2020
• Results First Posted: August 26, 2019

Record last verified: 2020-01

Locations

US (1)