Condition category
Surgery
Date applied
29/11/2004
Date assigned
06/01/2005
Last edited
03/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dirk Stengel

ORCID ID

Contact details

Clinical Epidemiology Division
Dept. of Trauma and Orthopaedic Surgery
Unfalllkrankenhaus Berlin
Warener Str. 7
Berlin
12683
Germany
stengeldirk@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SPOT

Study hypothesis

Added 13/08/09:
The RigidFix® system preserves graft tension gained during surgery, and leads to lower KT-1000 arthrometer side-to-side differences than the BioCryl® screw after six months of follow-up.

As of 13/08/09 this record has been extensively updated. All updates appear in the relevant field with the above update date.

Ethics approval

Not provided at time of registration

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Reconstructive surgery for anterior cruciate ligament (ACL) deficiency

Intervention

Patients will undergo standardised, arthroscopic ACL replacement by four-stranded hamstring tendon grafts. During surgery, participants will be randomised to transplant fixation by resorbable poly-L-lactide pins (experimental group) or poly-L-lactide/hydroxyapatite screws (control group). No other changes will apply in the treatment protocol. We will compare the residual anterior knee laxity at 3- and 6- months-follow-up between both methods.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Added 13/08/09
Side-to-side (repaired to healthy knee) difference in anterior translation as measured by the KT-1000 arthrometer at a defined load (89 N) six months after surgery

Secondary outcome measures

Added 13/08/09:
1. Generic and disease-specific measures of quality of life evaluated by:
1.1. Lysholm scale
1.2. Tegner score
1.3. International Knee Documentation Committee evaluation form (IKDC) German translation
2. Magnetic resonance imaging morphology of transplants and devices

Overall trial start date

01/12/2004

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Female and male patients >18 years with closed tibial metaphyses, a first event of a unilateral ACL rupture, proven by arthroscopy or magnetic resonance imaging (MRI) scanning, scheduled for ACL replacement surgery.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

54

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/12/2004

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Germany

Trial participating centre

Clinical Epidemiology Division
Berlin
12683
Germany

Sponsor information

Organisation

Emergency Hospital, Berlin (Unfallkrankenhaus Berlin) (Germany)

Sponsor details

Warener Str. 7
Berlin
12683
Germany
stengeldirk@aol.com

Sponsor type

Hospital/treatment centre

Website

http://www.ukb.de

Funders

Funder type

Other

Funder name

No sponsoring by third parties

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15723704
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19483077

Publication citations

  1. Protocol

    Stengel D, Matthes G, Seifert J, Tober V, Mutze S, Rademacher G, Ekkernkamp A, Bauwens K, Wich M, Casper D, , Resorbable screws versus pins for optimal transplant fixation (SPOT) in anterior cruciate ligament replacement with autologous hamstring grafts: rationale and design of a randomized, controlled, patient and investigator blinded trial [ISRCTN17384369]., BMC Surg, 2005, 5, 1, doi: 10.1186/1471-2482-5-1.

  2. Results

    Stengel D, Casper D, Bauwens K, Ekkernkamp A, Wich M, Bioresorbable pins and interference screws for fixation of hamstring tendon grafts in anterior cruciate ligament reconstruction surgery: a randomized controlled trial., Am J Sports Med, 2009, 37, 9, 1692-1698, doi: 10.1177/0363546509333008.

Additional files

Editorial Notes