Clinical trial NCT00858598: Pro Osteon Bone Void Filler Study
Official title: Pro Osteon Bone Void Filler Data Collection
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Osteoarthritis
Revision Arthroplasty
Keywords: Total Knee Arthroplasty
Revision
Tibial
Void
Bone Filler
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2009-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who fit within the inclusion / exclusion criteria of the FDA cleared indications for use.

Brief summary: This study was designed to observe the outcomes of Pro Osteon according to its cleared indications for use.

Detailed description: The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of Pro Osteon® as a Bone Void Filler. FDA has cleared this device via premarket notifications 510(k) K063346, K980817, and K990131. There will be no experimental or investigational devices used.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria will be the same as the stated indications stated in the summary of the FDA approved 510(k) K063346, K980817, and K990131 application. These indications are stated below:

* PRO OSTEON® 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
* PRO OSTEON® 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e, the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PRO OSTEON® 500R can be combined with autogenous blood, and/or sterile fluids (saline or Ringer's solution). The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
* Surgical techniques and patient care are to be standard for the surgeon participating in the protocol and should be maintained the same throughout the course of the data-collection.
* All patients must sign an IRB-approved Informed Consent to be enrolled into the study.

Exclusion Criteria:

Exclusion criteria will be the same as the stated contraindications stated in the summary of the FDA approved 510(k) K063346, K980817, and K990131 application. These contraindications are stated below:

* Pro Osteon® 500R Resorbable Bone Graft Substitute is contraindicated for fractures of the growth plate
* For segmental defects
* For indications which may be subjected to excessive impact or stresses
* When there is significant vascular impairment proximal to the graft site
* When there are metabolic or systemic bone disorders that affect bone or wound healing
* In infected sites
* When stabilization of the defect is not possible.
* The use of Pro Osteon® 500R is also contraindicated in cases where intraoperative soft tissue coverage is not planned or possible.

Primary outcomes:
measure: Radiographic Evaluation
timeFrame: 3 Years
Secondary outcomes:
measure: Knee Society Score
timeFrame: 3 Years
Other outcomes:
Locations:
Study officials:
References:
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citation: Chapman MW: Bone grafting. Chapman MW, Madison M (eds.): Operative Orthopaedics. Philadelphia, JB Lippincott, 1993, pp 139-49
citation: Lewonowski K, Dorr LD. Revision of cementless total knee arthroplasty with massive osteolytic lesions. J Arthroplasty. 1994 Dec;9(6):661-3. doi: 10.1016/0883-5403(94)90121-x. No abstract available.
citation: Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.
citation: Amstutz HC, Thomas BJ, Jinnah R, Kim W, Grogan T, Yale C. Treatment of primary osteoarthritis of the hip. A comparison of total joint and surface replacement arthroplasty. J Bone Joint Surg Am. 1984 Feb;66(2):228-41.