OVOSIS PUTTY Piolt study

Not Applicable

Completed

Conditions: Diseases of the musculoskeletal system and connective tissue

Registration Number: KCT0005259

Lead Sponsor: Asan Medical Center

Brief Summary: 1. Information on the subjects of the study - Target number of people: 30 -Number of people screened: 31 -Number of registered persons: 30 (one failed screening) *Number of registered persons by institution -Chungbuk National University Hospital: 10 patients (7 completed / 3 dropped out) -Seoul Asan Medical Center: 15 patients (11 completed / 4 dropped out) -Gangnam Severance Hospital: 5 people (2 completed / 3 dropped out) 2. the results of the study Primary Validation Variables: CT scan bone union rate at 52 weeks of surgery (%) - 100% union rate Secondary Validation Variables: CT scan bone union rate at 26, 39, and 104 weeks after surgery (%) -26 weeks 80.77% and 39 weeks 78.26% (three people were eliminated and parameters changed), and 104 weeks 100% 3. Abnormal reactions, including significant adverse reactions that occurred during the study, and their contents There were two adverse reactions, glaucoma and lower backpain, but they were not significant adverse reactions, and both cases had mild risk and had little relevance to medical devices. 4. Outcome Summary Thirty target subjects were registered, and the CT bone union rate at 52 weeks of surgery, the primary validation item, was measured 100%.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

A subject need to meet the following conditions.
1)Male or female subjects between 18 and 80 years of age.
2)Subjects who diagnosed Degenerative Disc Disease at one or two level from L2 to S1
?Spinal stenosis
?Herniated Intervertebral disc
?Spondylolisthesis or spondylosis
3) Those who are willing to participate in the trial, comply with treatment and procedures, and visit the hospital for evaluation of all observations.
4)A person who has voluntarily signed a written consent after hearing the purpose and method of this clinical trial.

Exclusion Criteria

1) Those who have a history of spinal surgery or tumor removal at the application site
2) Those with a history of fusion or intervertebral disc replacement in the lumbar region
3) Examples of serious metabolic diseases affecting bone growth, Paget's disease, osteoporosis, osteopenia, myeloma factors
4) Patients with severe osteoporosis, such as those with osteoporosis with an average T score < 3.0 of the lumbar spine L1 to L4 on the DEXA bone density test
5) Patients with hypersensitivity to Hydroxyapatite, rhBMP 2
6) Persons who cannot prohibit drugs that may affect bone metabolism during the prohibition period
7) People with systemic infection and/or acute infection at the site of application.
8) Those who have a history of drug and alcoholism within 2 years
9) It is possible to register if the child's disease with a history of malignancy has been cured and has not relapsed in the past 5 years.
10) Subjects deemed difficult to perform this clinical trial at the judgment of the responsible researcher
11) People with congenital bone and/or spinal cord abnormalities that may affect spinal safety
12) Those who are pregnant or lactating, who are planning to become pregnant during this trial or who do not agree with medically acceptable contraceptive methods.
* Medically acceptable contraceptive methods: condoms, oral contraception for at least 3 months, contraceptives for injection or implantation, intrauterine contraceptives, etc.
13) Those who cannot understand the purpose and method of the clinical trial
14) Participants who participated in another medical device intervention clinical trial within 6 months before participating in this trial.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone fusion rate on CT after surgery (%)

Secondary Outcome Measures

Name	Time	Method
CT fusion after surgery;X-ray fusion after surgery;ODI score changes compared to before surgery;SF 36 score changes compared to before surgery;VAS score changes compared to before surgery