Long-term Outcome of Partial Trapeziectomy with Interposition of Poly-L/D-lactide Scaffold (RegJoint) Vs. Autologous Tendon for Inflammatory Trapeziometacarpal Joint Arthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Hand pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Symptomatic end- stage inflammatory arthritis of the trapeziometacarpal joint
- •Trapeziometacarpal arthroplasty at Rheumatism Foundation Hospital, Heinola between january 2004 and december 2005
- •Signed written informed consent
排除标准
- •for the original study:
- •age less than 18 years
研究组 & 干预措施
Tendon interposition arthroplasty
Trapeziometacarpal arthroplasty using autologous tendon interposition to fill the space left by resecting affected joint surfaces.
干预措施: Tendon interposition arthroplasty (Procedure)
Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty
Trapeziometacarpal arthroplasty using poly-L-D-lactic acid implant (RegJoint) interposition to fill the space left by resecting affected joint surfaces.
干预措施: Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty (Procedure)
结局指标
主要结局
Hand pain
时间窗: Approximately 15 years from enrollment
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.
Hand function
时间窗: Approximately 15 years from enrollment
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.
Hand grip strength
时间窗: Approximately 15 years from enrollment
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.
QuickDASH score
时间窗: The previous week before approximately 15 years from enrollment
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.
Hand range of motion
时间窗: Approximately 15 years from enrollment
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.
Box and block dexterity test
时间窗: Approximately 15 years from enrollment
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,
Simulated activities of daily living tests
时间窗: Approximately 15 years from enrollment
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.
Radiological results
时间窗: Approximately 15 years from enrollment
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.
Patient Rated Wrist/Hand Evaluation clinical outcome measure
时间窗: The previous week before approximately 15 years from enrollment
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.
次要结局
未报告次要终点
研究者
Thomas Mikael Hackenberg
Doctoral student
Helsinki University Central Hospital