Mini Stem Radiostereometric Analysis Study

NCT01064531 | Completed Results FDA Device

• 1 other identifier: US-CR-130
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device. This study will document any device-related surgical or post-operative complications and adverse radiographic observations. Subjects meeting the entrance criteria specified in this protocol will be randomized as they become available.

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (2)

• Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)

  Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.

  Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported

• Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)

  Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.

  Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported

Secondary Outcomes (18)

• Preoperative Total Harris Hip Score (HHS)

  Preoperative

• 3 Months Postoperative Total Harris Hip Score (HHS)

  3 months postoperative

• 1 Year Postoperative Total Harris Hip Score (HHS)

  1 year postoperative

• 2 Years Postoperative Total Harris Hip Score (HHS)

  2 years postoperative

• 3 Years Postoperative Total Harris Hip Score (HHS)

  3 years postoperative

Study Arms (2)

MIS Femoral Neck Stem

Subject will be randomized to either MIS or Synergy implant.

Device: MIS Femoral Neck Stem implant

Synergy Hip System

Subject will be randomized to either Synergy or MIS implant.

Device: MIS Femoral Neck Stem implant

Interventions

MIS Femoral Neck Stem implant DEVICE

MIS Femoral Neck Stem; Synergy Hip System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The purpose of the current investigation is to compare migration of the device after implantation with a modular, short hip stem called the "MIS Stem" or a standard THA using the Synergy Hip System using RSA. The intended use of this product is for patients with inflammatory and non-inflammatory degenerative joint disease who require a primary total hip replacement.

You may qualify if:

• Subject has hip disease that requires a total hip arthroplasty.
• Subject is willing to consent to participation in the study.
• Subject plans to be available for follow-up through study duration.
• Subject is of stable health and is free of or treated and stabilized for any condition that would prose excessive operating risk.

You may not qualify if:

• Subject has insufficient femoral bone stock.
• Subject has had major non-arthroscopic surgery to the study hip.
• Subject has physical, emotional or neurological conditions that would compromise the subjects compliance with postoperative rehabilitation and follow-up.
• Subject has a known sensitivity to materials in the device.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

London Health Sciences Center- University Hospital

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

There was a decreased compliance rate at the 3-year follow-up visit and an increased termination rate by the 5-year follow-up visit resulting in smaller sample sizes for data collection.

Results Point of Contact

• Title: Tracey Brengola, MS
• Organization: Smith & Nephew, Inc

Tracey.brengola@smith-nephew.com

978-749-1491

Study Officials

• Richard McCalden, MD

  London Health Science Center

  PRINCIPAL INVESTIGATOR

• Beate Hanson, MD, PhD

  Vice President, Global Clinical Strategy and Global Clinical Operations

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 8, 2010
• Study Start: June 30, 2009
• Primary Completion: April 22, 2016
• Study Completion: April 22, 2016
• Last Updated: April 9, 2020
• Results First Posted: April 9, 2020

Record last verified: 2020-04

Locations

CA (1)