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Completed

NCT Number: NCT00679328

OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions

This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the healing rates of the OP Device to that of autograft.

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Key information

Conditions

Tibial Nonunions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mesa, Arizona, United States

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About this study

This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the clinical safety and effectiveness (healing rates) of the OP Device to that of traditional bone autografts to repair nonunions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must show radiographic skeletal maturity
  • Documented evidence of previous fracture management
  • Nonunion in the tibia and candidate to receive bone autografts and intramedullary (IM) Nail fixation
  • Nonunion gap must not exceed half the diameter of the bone at the site of fracture, as assessed radiographically prior to study treatment

Exclusion criteria

  • Patients who do not have adequate vascularity to permit healing
  • Patients with inadequate skin coverage
  • Patients with chronic use of steroidal medications
  • Patients with active infection systemically or at the site of nonunion.

Treatment and study plan

Surgical implantation of OP-1 device or autograft bone graft material

Device

Surgical implantation of OP-1 device or autograft bone graft material

Primary outcomes

  1. No further retreatment of the surgical site, function and pain at the site of the nonunion, evidence of bridging.

    Time frame: 3, 6, 9, 12, 24 months

Secondary outcomes

  1. Medical events, treatment related events, laboratory tests, medication use.

    Time frame: 3, 6, 9, 12, 24 months

Sponsors and collaborators

Lead sponsor

Olympus Biotech Corporation

Industry

Registry information

Official study title

Study #91-01 - A Randomized Study of the Stryker OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions

Important dates

Study start
1992
Primary completion
1996
Study completion
1999
First posted
May 16, 2008
Registry last updated
Jun 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.