An interventional study of Tendon interposition arthroplasty and Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty in Rheumatoid Arthritis (RA), sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
This is a late (about 15 years) follow-up study of a randomized prospective clinical study originally conducted as a collaboration of the Rheumatism Foundation Hospital, Heinola, Finland and Päijät-Häme Central Hospital, Lahti Finland.
For the original study thirty-five patients with symptomatic end-stage inflammatory arthritis of the trapeziometacarpal joint were recruited. All patients signed written informed consent and were randomised to undergo surgery using either tendon interposition or poly-L-D-lactic acid implant interposition arthroplasty of said joint. The study was approved by the Päijät-Häme hospital district ethics committee.
Results of up to two years of follow-up have been published previously (DOI: 10.3109/2000656X.2012.669202).
For the current study all patients included in the final data analysis of the original study are to be contacted for a late follow-up using the same metrics used in the original study (hand pain and hand function rated on a visual analogue scale, hand strenght measurements, hand range of motion measurements, hand dexterity tests and tests simulating hand function in activities of daily living). Additionally outcomes will be assessed using the Patient Rated Wrist/Hand Evaluation and QuickDASH clinical outcome measurement scores.
Collected follow-up data will be statistically analyzed and a summary will be published in a peer-reviewed scientific journal.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 21 is below the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteriria:
Patients of the study the results of which are reported in the following article: DOI: 10.3109/2000656X.2012.669202
Inclusion criteria for the original study:
Exclusion criteria for the original study:
-age less than 18 years
Trapeziometacarpal arthroplasty using autologous tendon interposition to fill the space left by resecting affected joint surfaces.
Procedure: Tendon interposition arthroplasty
Trapeziometacarpal arthroplasty using poly-L-D-lactic acid implant (RegJoint) interposition to fill the space left by resecting affected joint surfaces.
Procedure: Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty
Trapeziometacarpal arthroplasty using autologous tendon interposition to fill the space left by resecting affected joint surfaces.
Trapeziometacarpal arthroplasty using poly-L-D-lactic acid implant (RegJoint) interposition to fill the space left by resecting affected joint surfaces.
Hand pain
Pain of the studied / operated hand using a 0-100mm visual analogue scale where 0mm denotes no pain at all and 100mm denotes worst pain imaginable.
Time frame: Approximately 15 years from enrollment
Hand function
Function of the studied / operated hand using a 0-100mm visual analogue scale where 0mm denotes normal hand function and 100mm denotes the hand not functioning at all.
Time frame: Approximately 15 years from enrollment
Hand grip strength
Power grip strength (in kg) measured using a jamar hand dynamometer. Key pinch and tip pinch strength (in kg) mearured using a mechanical pinch gauge.
Time frame: Approximately 15 years from enrollment
QuickDASH score
The Disabilities of the Arm, Shoulder, and Hand (DASH) is a clinical outcome measure questionnaire consisting of thirty questions and has been validated several times. The QuickDASH score includes eleven of those questions and has been validated as well. Both scores are used to evaluate upper limb function and symptoms during the previous week.
Time frame: The previous week before approximately 15 years from enrollment
Hand range of motion
Active range of motion for following joints / parts of the hand: trapeziometacarpal joint radial abduction, thumb metacarpophalangeal joint extension and flexion, thumb interphalangeal joint extension and flexion.
Time frame: Approximately 15 years from enrollment
Box and block dexterity test
The Box and block dexterity consists of a rectangular box with a central dividing wall. The box is set on a table in front of the patient in a lengthwise orientation with the dividing wall at the patients midline. At the beginning of the test all 150 wooden cubes each 2,5cm are placed in the compartment on the side of the hand being tested. The test performed by moving as many 2,5cm wooden cubes one by one by hand from one box to another within 60 seconds as possible. Before the actual test the patient practices performing the test for 15 seconds with each hand,
Time frame: Approximately 15 years from enrollment
Simulated activities of daily living tests
Decanting water from a jug gripping the jug by its handle into a glass / cup. Decanting water from a glass / cup into jug gripping the glass with a palm grip. Cutting medical putty disc with knife and fork simulating cutting food on a plate. Picking up a wooden bead approximately 1cm in diameter using a pinch grip. The test is repeated four times for each hand so that the patient always uses their thumb but the opposing finger is different each time. Grading for all tests: Normal grip / adapted grip / unable to perform.
Time frame: Approximately 15 years from enrollment
Radiological results
Trapeziometacarpal joint (sub)luxation, joint trapeziometacarpal joint space height and bone destruction adjacent to the trapeziometarcpal joint using posterior to anteriot as well as lateral plain radiographs.
Time frame: Approximately 15 years from enrollment
Patient Rated Wrist/Hand Evaluation clinical outcome measure
The Patient-Rated Wrist and Hand Evaluation questionnaire is a region specific, patient reported outcome measure that aims to evaluate pain and disability of the wrist and hand. In one question the patient is asked about their hand / wrist today, while in fifteen questions the patient is asked about their hand / wrist this week. The score has been validated multiple times.
Time frame: The previous week before approximately 15 years from enrollment
Plan to share: Undecided — At present we have no plan to share IPD as local legislature and the study protocol do not allow us to do so. If other researchers were to ask us to share IPD, we would be happy to apply permission to do so from our institution.
Ran from Oct 2019 to primary completion in Apr 2020, 5 months.
Of 262 non-industry interventional studies with no phase under Arthritis, Rheumatoid, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's 5 months is below that.
Counting every sponsor, half of 301 studies reached it within 26 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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