PMCF Study on PEEK Suture Anchors for Hip Indications

NCT ID: NCT03814044

Last Updated: 2024-10-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-10

Study Completion Date

2019-09-10

Brief Summary

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Post-market clinical follow-up (PMCF) on the PEEK Suture Anchors in the hip.

Detailed Description

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Conditions

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Soft Tissue to Bone Fixation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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PEEK Suture Anchors

Subjects who have undergone hip joint repair using PEEK Suture Anchors:

BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjects who have undergone hip joint repair using the study devices.
2. Subjects aged 18 years and older at the time of surgery.
3. Subjects who had a visit to their provider between 3 and 15 months postoperative.

Exclusion Criteria

1. Subjects who are \< 12 months post-operative.
2. Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery
3. Subject had off-label use of the PEEK suture anchor during surgery.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smith & Nephew, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judith Horner

Role: STUDY_CHAIR

Smith & Nephew, Inc.

Locations

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DMOS Orthopedic Centers

West Des Moines, Iowa, United States

Site Status

Center for Advanced Orthopedic and Sports Medicine

Auburn Hills, Michigan, United States

Site Status

Community Hospital - Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Southwest Orthopaedic Reconstructive Specialists

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2018.14.SMD.PEEK.RET.HIP

Identifier Type: -

Identifier Source: org_study_id

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