NCT02918734

Brief Summary

In this randomized controlled trial the investigators will compare the results after primary anterior cruciate ligament (ACL) reconstruction using two different methods for femoral fixation of a bone-patellar tendon-bone (BPTB) autograft. Interference screws have been the standard method for fixing the femoral side of BPTB grafts; however, several pitfalls have been reported. Cortical fixation with the Endobutton CL BTB Fixation System has become available and the clinical results have been described as promising; however, no randomized controlled trials comparing these two femoral fixation methods have been conducted, and there is no published data that confirms that the bone block heals in the tunnel with the newer method. The aim of our study is to compare the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
83mo left

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Oct 2016Mar 2033

First Submitted

Initial submission to the registry

June 20, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2033

Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

10.2 years

First QC Date

June 20, 2016

Last Update Submit

July 9, 2025

Conditions

Knee Injuries

Keywords

Anterior Cruciate LigamentBone-Patellar Tendon-Bone Grafting

Outcome Measures

Primary Outcomes (1)

  • Knee related quality of life

    KOOS subscale "knee related Quality of life (QOL)"

    2 years

Secondary Outcomes (13)

  • Tegner activity scale

    6 months, 2 years, 10 years

  • Lachman test

    6 weeks, 6 months, 2 years, 10 years

  • Muscular strength

    6 months, 2 years, 10 years

  • Bone block integration

    6 months

  • Osteoarthritis

    2 years, 10 years

  • +8 more secondary outcomes

Other Outcomes (2)

  • Complications

    Up to 10 years

  • Reoperations

    Up to 10 years

Study Arms (2)

Endobutton CL BTB

EXPERIMENTAL

Femoral fixation of the BPTB autograft with the Endobutton CL BTB Fixation System.

Device: Endobutton CL BTB

Metal interference screw

ACTIVE COMPARATOR

Femoral fixation of the BPTB autograft with a metal interference screw.

Device: Metal interference screw

Interventions

Endobutton CL BTBDEVICE

ACL reconstruction with Endobutton CL BTB

Endobutton CL BTB
Metal interference screwDEVICE

ACL reconstruction with metal interference screw

Metal interference screw

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primary reconstruction of ACL ruptures
  • Surgery at least 6 weeks after injury
  • The patient must accept and sign the informed consent form before surgery

You may not qualify if:

  • Medical indication for using another graft than BPTB autograft (such as history of anterior knee pain or occupations etc. requiring frequent kneeling)
  • Previous major surgical procedures in the same knee
  • Major additional injuries in the knee (posterior cruciate ligament, lateral collateral ligament, medial collateral ligament, sutured meniscus lesions and major cartilage lesions undergoing cartilage repair)
  • Contralateral ACL injury (treated or untreated)
  • Present or former serious illness that makes follow-up or rehabilitation difficult (e.g. alcohol or drug abuse, psychiatric disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Orthopedic Surgery, St Olavs Hospital

Trondheim, Norway

RECRUITING

Rosenborgklinikken

Trondheim, Norway

RECRUITING

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Jon Olav Drogset, md phd

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Trond Olav Lundemo, md

CONTACT

TrondOlav.Lundemo@helse-nordtrondelag.no

Tone Gifstad, md phd

CONTACT

tone.gifstad@stolav.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

September 29, 2016

Study Start

October 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2033

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)