## Protocol Section
### Identification Module
**NCT ID:** NCT01224379

**Acronym:** Topping-off

**Brief Title:** Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine

**Official Title:** Clinical Trial of the Efficacy of Hybrid Systems(Topping Off)in Comparison to the Conventional Spondylodesis in Fusion-surgery in the Lumbal Spine: a Prospective, Randomised Study

#### Organization Study ID Info
**ID:** Uni-Köln-1223
#### Organization
**Class:** OTHER
**Full Name:** University of Cologne
#### Secondary ID Infos
**Domain:** University of Cologne
**ID:** Uni-Köln-1223
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2012-10

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2010-10-20

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-10-19

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2012-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2011-01

**Status Verified Date:** 2010-09

#### Study First Post Date
**Date:** 2010-10-20
**Type:** ESTIMATED
**Study First Submit Date:** 2010-10-19
**Study First Submit QC Date:** 2010-10-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Cologne

#### Responsible Party

**Old Name Title:** University of Cologne

**Old Organization:** Medizinische Fakultät der Universität zu Köln

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome?

**Detailed Description:** Primary efficacy endpoint:

The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).

Key secondary endpoint(s):

1. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36
2. Individual dimensions of the Oswestry Disability Index (ODI)
3. Time until radiological adjacent instability and comparison to the clinical outcome
4. Capacity of work at the time of surgery and after surgery, time until return to work

Assessment of safety:

1. Treatment complication in control and intervention groups (SAE-management)
2. A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias

### Conditions Module

**Conditions:**

- Spondylolisthesis

- Erosive Osteochondrosis in L2-S1

**Keywords:**

- Lumbar spine

- fusion

- adjacent instability

- topping-off.

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).

**Intervention Names:**

- Device: Topping off system

**Label:** Arm1: "topping off" system

**Type:** OTHER

#### Arm Group 2

**Description:** The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)

**Intervention Names:**

- Device: monosegmental PLIF

**Label:** Arm 2: monosegmental PLIF

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm1: "topping off" system

**Description:** The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).

**Name:** Topping off system

**Other Names:**

- Topping off

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Arm 2: monosegmental PLIF

**Description:** The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)

**Name:** monosegmental PLIF

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Primary efficacy endpoint:

The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).

**Measure:** SF36

**Time Frame:** 6 Month

#### Secondary Outcomes

**Description:** 1. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36 follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline

**Measure:** 1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36

**Time Frame:** 6 weeks

**Description:** Assessment of safety:

1. Treatment complication in control and intervention groups (SAE-management)
2. A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias

**Measure:** Safety

**Time Frame:** all time

**Description:** Individual dimensions of the Oswestry Disability Index (ODI) follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline

**Measure:** Individual dimensions of the Oswestry Disability Index (ODI)

**Time Frame:** 6weeks

**Description:** Time until radiological adjacent instability and comparison to the clinical outcome follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline

**Measure:** Time until radiological adjacent instability and comparison to the clinical outcome

**Time Frame:** 6 weeks

**Description:** Capacity of work at the time of surgery and after surgery, time until return to work follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline

**Measure:** Capacity of work at the time of surgery and after surgery, time until return to work

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** Key inclusion criteria:

1. Male or female \>30 years of age
2. Lumbar spine pathology with indication for monosegmental PLIF
3. Radiological signs of a degeneration of the adjacent segment without instability

Key exclusion criteria:

1. Radiological signs of existing instability of the adjacent segment 2. Normal endplates and no disc desiccation in MRI in the adjacent seg-ment 3. Previous surgery of the lumbar spine

-

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** studienzentrum-ortho-unfall@uk-koeln.de

**Name:** Jan Siewe, Dr.

**Phone:** +49-221-478-87294

**Role:** CONTACT

**Contact 2:**

**Email:** studienzentrum-ortho-unfall@uk-koeln.de

**Name:** Margarete Wicharz

**Phone:** +49-221-478-87294

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cologne

**Contacts:**

***Contact 1:***

- **Email:** studienzentrum-ortho-unfall@uk-koeln.de

- **Name:** Jan Siewe, Dr.

- **Phone:** +49-221-478-87294

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jan Siewe, Dr.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Germany

**Facility:** University of Cologne, Department of Orthopedics& traumasurgery

**Zip:** 50931

#### Overall Officials

**Official 1:**

**Affiliation:** University of Cologne

**Name:** Jan Siewe, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Siewe J, Otto C, Knoell P, Koriller M, Stein G, Kaulhausen T, Eysel P, Zarghooni K, Franklin J, Sobottke R. Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2011 Oct 18;12:239. doi: 10.1186/1471-2474-12-239.

**PMID:** 22008088

#### See Also Links

**Label:** Related Info

**URL:** http://orthopaedie.uk-koeln.de/forschung

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013169

- Term: Spondylolysis

- ID: D000055009

- Term: Spondylosis

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15963

- Name: Spondylolisthesis

- Relevance: HIGH

- As Found: Spondylolisthesis

- ID: M28008

- Name: Osteochondrosis

- Relevance: HIGH

- As Found: Osteochondrosis

- ID: M15964

- Name: Spondylolysis

- Relevance: LOW

- As Found: Unknown

- ID: M27993

- Name: Spondylosis

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4302

- Name: Osteochondrosis

- Relevance: HIGH

- As Found: Osteochondrosis

### Condition Browse Module - Meshes

- ID: D000013168

- Term: Spondylolisthesis

- ID: D000055034

- Term: Osteochondrosis

### Misc Info Module

- Version Holder: 2024-05-24
