## Protocol Section
### Identification Module
**NCT ID:** NCT03388879

**Acronym:** NAFTI

**Brief Title:** Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures

**Official Title:** Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures

#### Organization Study ID Info
**ID:** REKC 2010/1706
#### Organization
**Class:** OTHER
**Full Name:** Oslo University Hospital
### Status Module
#### Completion Date
**Date:** 2016-06-21

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-01-03

**Type:** ACTUAL

**Last Update Submit Date:** 2017-12-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-06-16

**Type:** ACTUAL

#### Start Date
**Date:** 2010-10-31

**Type:** ACTUAL

**Status Verified Date:** 2017-12

#### Study First Post Date
**Date:** 2018-01-03
**Type:** ACTUAL
**Study First Submit Date:** 2017-12-17
**Study First Submit QC Date:** 2017-12-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Sahlgrenska University Hospital, Sweden

#### Lead Sponsor

**Class:** OTHER

**Name:** Oslo University Hospital

#### Responsible Party

**Investigator Affiliation:** Oslo University Hospital

**Investigator Full Name:** Frede Frihagen

**Investigator Title:** Consultant

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a randomised, bi-centre, prospective, clinical trial in patients with closed tibia shaft fractures. The fracture should be fresh/acute and seen within 3 weeks after the injury. Patients will be randomised to surgery with either a Taylor Spatial Frame (Smith \& Nephew, England) or a reamed intramedullar nail (according to local choice) with locking screws. Primary outcome measure is the physical component summary (PCS) of RAND Short form 36 (SF-36) after 2 years. Among secondary outcomes: Visual Analogue Scale (VAS) for pain, complications, healing, malunion, and resource use.

**Detailed Description:** Fractures of the lower leg (fractures of the tibia shaft with or without concurrent fracture of the fibula) are a common injury. According to our fracture register 95 patients with closed tibia fractures were operated the last 3 years at our department. Fractures with moderate or no displacement can be successfully treated with a cast and subsequent Sarmiento brace. Displaced fractures are commonly treated with an intramedullary nail. Intramedullary nailing yields a high rate of union. More than 50 % of operated patients do, however, develop chronic anterior knee pain and one third of the patients have pain at rest. This contributes a big problem for many patients both at spare time and at work. Another problem is significant rates of malunion.

The use of ring fixators utilizing rings and 1,8 mm. wires was introduced by Gavril Ilizarov more than 50 years ago, and the technique has been further developed through the introduction of six adjustable struts (Taylor Spatial Frame). This hexapod circular frame allows accurate reduction as well as a high stability. The ring fixator is less invasive and allows early weight bearing, but may be cumbersome to the patient. There is also concern about pin-tract infection, osteomyelitis and joint contracture.

Only one prior study has compared ring fixator (Ilizarov) and intramedullar nail in closed tibia fractures. The results showed significant less anterior knee pain in the patients operated with ring fixator, but the study design did not allow clear conclusion.

### Conditions Module

**Conditions:**

- Tibial Fractures

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Prospective randomized two-group clinical trial with block randomization.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** The researcher doing the statistical analyses will be masked for treatment Group (i.e. Group 1 or 2) in a databse blinded for treatment grioups and without variables indirectly revealing treatmnet arm. These will be analyzed later.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 65

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** A Taylor Spatial Frame should consist of 2 rings with 4 half pins/K-wire attached to each ring. If possible 3, not hydroxyapatite-coated, half pins and one K-wire should be attached to each ring. The half pins/K-wire should be spread in distance and direction for optimum stability.

**Intervention Names:**

- Device: Taylor Spatial Frame

**Label:** Circular frame external fixator

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Nailing technique according to Karladani and Styf published technique (ref: Karladani AH, Styf J. Percutaneous intramedullary nailing of tibial shaft fratures: a new approach for prevention of anterior knee pain. Injury, Int. J. Care Injury 32 (2001) 736-39)

**Intervention Names:**

- Device: Intramedullary nail

**Label:** Intramedullary nail

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Circular frame external fixator

**Description:** Circular external fixator

**Name:** Taylor Spatial Frame

**Other Names:**

- Circular frame

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Intramedullary nail

**Description:** Antegrade intramedullary nail

**Name:** Intramedullary nail

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better.

**Measure:** Physical Component summary of RAND SF 36 (Short Form 36)

**Time Frame:** 24 months

#### Secondary Outcomes

**Description:** Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

**Measure:** Vitality Subscore of RAND (SF) 36

**Time Frame:** 6, 12, 24 months

**Description:** Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

**Measure:** Physical functioning, subscore of RAND (SF) 36

**Time Frame:** 6, 12, 24 months

**Description:** Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

**Measure:** Bodily pain, subscore of RAND (SF) 36

**Time Frame:** 6, 12, 24 months

**Description:** Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

**Measure:** General health perceptions, subscore of RAND (SF) 36

**Time Frame:** 6, 12, 24 months

**Description:** Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

**Measure:** Physical role functioning, subscore of RAND (SF) 36

**Time Frame:** 6, 12, 24 months

**Description:** Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

**Measure:** Emotional role functioning, subscore of RAND (SF) 36

**Time Frame:** 6, 12, 24 months

**Description:** Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

**Measure:** Social role functioning, subscore of RAND (SF) 36

**Time Frame:** 6, 12, 24 months

**Description:** Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

**Measure:** Mental health, subscore of RAND (SF) 36

**Time Frame:** 6, 12, 24 months

**Description:** Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better.

**Measure:** Physical Component summary of RAND (SF) 36

**Time Frame:** 6, 12 months

**Description:** VAS scale 0-10

**Measure:** Pain around the knee

**Time Frame:** 6, 12, 24 months

**Description:** VAS scale 0-10

**Measure:** Pain around the fracture site

**Time Frame:** 6, 12, 24 months

**Description:** VAS scale 0-10

**Measure:** Pain around the ankle

**Time Frame:** 6, 12, 24 months

**Description:** Compartment syndrome, sequela compartment syndrome (e.g. short foot, clawing, neurological disorder), infection that needs operation, any unexpected reoperation (except removal of single pins or screws)

**Measure:** Complications major (composite)

**Time Frame:** 24 months

**Description:** pin tract infection that needs antibiotics, wound complication that don't need reoperation, unexpected minor reoperations (i.e. removal of single pins or screws)

**Measure:** Complications minor (composite)

**Time Frame:** 24 months

**Description:** Minor reoperation (e.g. remove/exchange pins, remove/exchange screws)

**Measure:** Reoperations minor (composite)

**Time Frame:** 6, 12, 24 months

**Description:** Major reoperation (e.g. fasciotomy, exchange nail, surgery for refracture, revision for infection, surgery for non-union)

**Measure:** Reoperations major (composite)

**Time Frame:** 6, 12, 24 months

**Description:** Time to fracture union in days. We require both radiographical union defined by callus bridging 3 of 4 cortices AND clinical union defined by full, pain free and unaided weight bearing.

**Measure:** Time to union (composite)

**Time Frame:** 6, 12, 24 months

**Description:** Number of days away from work for employed patients

**Measure:** Resource use; Away from work

**Time Frame:** 24 months

**Description:** Number of unscheduled contacts with hospital regarding tibia fracture

**Measure:** Resource use; Emergency contacts

**Time Frame:** 24 months

**Description:** Hospital stay in days for index stay

**Measure:** Resource use; Length of stay

**Time Frame:** 24 months

**Description:** Surgery time in minutes for index surgery

**Measure:** Resource use; Operation time

**Time Frame:** 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Closed tibia shaft fractures suited for both study treatments.
* A patient who is informed of the purpose of the investigation and who has given informed consent and willingness to accept randomisation either to Taylor Spatial Frame or intramedullary nailing.
* Willingness and ability to comply with all investigation procedures
* Age between 18 to 70 years
* Skeletally mature
* Previous unaided walking

Exclusion Criteria:

* Participation in other clinical investigations that will interfere with this study
* Mental illness or other conditions that preclude ring fixator in the judgment of the investigator
* Any other concurrent condition(s) that, in the judgment of the investigator, would prohibit the patient from participation in the study
* No other injury or previous disease that would be likely to seriously influence the long term outcome (this will exclude e.g. osteomyelitis, vascular or neurological disorder of the lower extremities, rheumatoid artist, malignancy that could influence on bone healing)
* Compartment syndrome before randomisation
* Pathologic fracture
* Ongoing or previous use the last year of drugs that can be bone anabolic (e.g. anabolic steroids, growth hormone, parathyroid hormone)

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Oslo

**Country:** Norway

**Facility:** Orthopedic Center, Ulleval University Hospital

**Zip:** 0408

#### Overall Officials

**Official 1:**

**Affiliation:** Professor, head of research group

**Name:** Jan E Madsen, PhD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Description:** Depending on demand. No plan as of yet.

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000007869

- Term: Leg Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M26370

- Name: Fractures, Bone

- Relevance: HIGH

- As Found: Fracture

- ID: M16737

- Name: Tibial Fractures

- Relevance: HIGH

- As Found: Tibial Fractures

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050723

- Term: Fractures, Bone

- ID: D000013978

- Term: Tibial Fractures

### Misc Info Module

- Version Holder: 2024-05-24
