Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

A Pilot Study to Validate the Feasibility of Injecting and Monitoring Recombinant Human Bone Morphogenetic Protein-2/Calcium Phosphate Matrix (rhBMP-2/CPM) in Subjects With Open Wedge Osteotomies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00243295

Enrollment

Registered

2005-10-21

Start date

2003-11-30

Completion date

2005-03-31

Last updated

2006-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

osteoarthritis, deformity of knee

Brief summary

To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters: * Injecting the desired volume of rhBMP-2/CPM within the defect * Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2/CPM.

Interventions

DRUGrhBMP-2/CPM

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

ECT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Male or female subjects 45 to 70 years of age * Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment OA of the knee. * Female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for OWO and agree to use medically approved contraception for the duration of the study. Other inclusion applies.

Exclusion criteria

* Subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results. * Subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up. * Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma. Other exclusion applies.

Design outcomes

Primary

Measure	Time frame
Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies	—
Feasibility measures include	—
Injection of desired volume of rhBMP-2/CPM within the osteotomy defect	—
Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM.	—

Secondary

Measure	Time frame
Safety of administering different volumes of rhBMP-2/CPM in high tibial osteotomy defects. Safety assessed by evaluation of adverse events reported during the duration of the trial.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026